AzTrials
AzTrials

HyperfibrinogenemiaAPHERCOAGNCT06571552

Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

A study testing Single Plasma Exchange followed by Double Filtration Plasmapheresis in people with Hyperfibrinogenemia and Hemostatic Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperfibrinogenemia, Hemostatic Disorder
What is being tested?
Single Plasma Exchange followed by Double Filtration Plasmapheresis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
17 Dec 2024to 2 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.
  • Therapeutic plasmapheresis with regional citrate anticoagulation.
  • Patients over 18 years of age.
  • Patient affiliated to or benefiting from a social security scheme.
  • Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Who cannot join

  • Patients treated with oral anticoagulants or anti-platelet agents.
  • Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.
  • Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.
  • Patient in an exclusion period determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.
  • Pregnant or breast-feeding patients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Olivier MORANNE, Professor contact

+334.66.68.31.49

olivier.moranne@chu-nimes.fr

Anissa MEGZARI contact

+33466684236

drc@chu-nimes.fr

France1 site, 1 recruiting

  • CHU de Nîmes

    Nîmes, France, 30029

    Anne Clarisse SIMONET, PhD, 04.66.68.51.48, anne.clarisse.simonet@chu-nimes.fr

    Olivier MORANNE, MD

    Recruiting

Other trials in France

About this study

Official title: Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.

Read the detailed description

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis; however, most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present, such as severe renal failure. Furthermore, in these studies, assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors, whose molecular weight and half-life vary widely. To date, there is no clear consensus/recommendation on the management of haemostasis disorders secondary to therapeutic apheresis. The need to correct haemostasis disorders caused by therapeutic apheresis also appears to be consensual in cases of active bleeding.The methods of correcting haemostasis disorders can also be discussed between infusion of coagulation factor and fresh frozen plasma. Finally, apart from these clinical situations, it is not clear when changes in haemostasis associated with coagulation factor deficiency should be corrected. There are no studies available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, depending on the type of session and the fibrinogen level at the end of the session. The hypothesis of our research is that the existence of a link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and to propose preventive measures.

Being tested
Single Plasma Exchange followed by Double Filtration Plasmapheresis
Keywords
Double Filtration Plasmapheresis, Single Plasma Exchange
Medical subject headings
Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Plasma Exchange followed by Double Filtration PlasmapheresisProcedure or surgery

    Double Filtration Plasmapheresis followed by Single Plasma Exchange

Study groups in NCT06571552
Study groupRoleWhat they receive
Patients benefitting from Single Plasma Exchange followed by Double Filtration PlasmapheresisActive comparatorFor the patients in this group, the first cycle (T1) will consist of Single Plasma Exchange and the second cycle (T2) of Double Filtration Plasmapheresis.
Receives: Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis
Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma ExchangeActive comparatorFor the patients in this group, the first cycle (T1) will consist of Double Filtration Plasmapheresis and the second cycle (T2) of Single Plasma Exchange.
Receives: Procedure: Single Plasma Exchange followed by Double Filtration Plasmapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 0, before the session

  2. Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, before the session

  3. Determination of fibrinogen levels after the first plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 0, end of session

  4. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, end of session

  5. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 0, 1 hour after the session

  6. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, 1 hour after the session

  7. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 0, 4 hours after the session

  8. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, 4 hours after the session

  9. Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 1

  10. Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 1

  11. Determination of fibrinogen levels before the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Day 3

  12. Determination of fibrinogen levels with Genesia® before the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Day 3

  13. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Month 1, Day 1, 1 hour after the session

  14. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 1, 1 hour after the session

  15. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Month 1, Day 4, 4 hours after the session

  16. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 4, 4 hours after the session

  17. Determination of fibrinogen levels after the plasmapheresis session with single plasma exchange

    Clauss functional method, g/L

    Measured: Month 1, Day 3

  18. Determination of fibrinogen levels with Genesia® after the plasmapheresis session with single plasma exchange

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 3

  19. Determination of fibrinogen levels before the first plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 0, before the session

  20. Determination of fibrinogen levels with Génésia® before the first plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, before the session

  21. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 0, end of session

  22. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, end of session

  23. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 0, 1 hour after the session

  24. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, 1 hour after the session

  25. Determination of fibrinogen levels after the first plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 0, 4 hours after the session

  26. Determination of fibrinogen levels with Génésia® after the first plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 0, 4 hours after the session

  27. Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 1

  28. Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 1

  29. Determination of fibrinogen levels before the plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Day 3

  30. Determination of fibrinogen levels with Génésia® before the plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Day 3

  31. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Month 1, Day 1, 1 hour after the session

  32. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 1, 1 hour after the session

  33. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Month 1, Day 1, 4 hours after the session

  34. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 1, 4 hours after the session

  35. Determination of fibrinogen levels after the plasmapheresis session with double filtration plasmapheresis

    Clauss functional method, g/L

    Measured: Month 1, Day 3

  36. Determination of fibrinogen levels with Génésia® after the plasmapheresis session with double filtration plasmapheresis

    Automated thrombin generation test on Génésia®.

    Measured: Month 1, Day 3

Secondary outcomes (226)

  1. Complete blood count before the plasmapheresis session with single plasma exchange : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  2. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  3. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  4. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Quantitative, per microliter

    Measured: Day 1

  5. Complete blood count after the plasmapheresis session with single plasma exchange : White blood cells

    Quantitative, per microliter

    Measured: Day 3

  6. Complete blood count before the plasmapheresis session with single plasma exchange : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  7. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  8. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  9. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Quantitative, per microliter

    Measured: Day 1

  10. Complete blood count after the plasmapheresis session with single plasma exchange : Red blood cells

    Quantitative, per microliter

    Measured: Day 3

  11. Complete blood count before the plasmapheresis session with single plasma exchange : Hemoglobin

    Quantitative, grams per liter

    Measured: Day 0, Hour 0

  12. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Quantitative, grams per liter

    Measured: Day 0, Hour 1

  13. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Quantitative, grams per liter

    Measured: Day 0, Hour 4

  14. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Quantitative, grams per liter

    Measured: Day 1

  15. Complete blood count after the plasmapheresis session with single plasma exchange : Hemoglobin

    Quantitative, grams per liter

    Measured: Day 3

  16. Complete blood count before the plasmapheresis session with single plasma exchange : Platelets

    Quantitative, %

    Measured: Day 0, Hour 0

  17. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Quantitative, %

    Measured: Day 0, Hour 1

  18. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Quantitative, %

    Measured: Day 0, Hour 4

  19. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Quantitative, %

    Measured: Day 1

  20. Complete blood count after the plasmapheresis session with single plasma exchange : Platelets

    Quantitative, %

    Measured: Day 3

  21. Complete blood count before the plasmapheresis session with single plasma exchange : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  22. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  23. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  24. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Quantitative, per microliter

    Measured: Day 1

  25. Complete blood count after the plasmapheresis session with single plasma exchange : Neutrophils

    Quantitative, per microliter

    Measured: Day 3

  26. Complete blood count before the plasmapheresis session with single plasma exchange : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  27. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  28. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  29. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Quantitative, per microliter

    Measured: Day 1

  30. Complete blood count after the plasmapheresis session with single plasma exchange : Lymphocytes

    Quantitative, per microliter

    Measured: Day 3

  31. Complete blood count before the plasmapheresis session with single plasma exchange : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  32. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  33. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  34. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Quantitative, per microliter

    Measured: Day 1

  35. Complete blood count after the plasmapheresis session with single plasma exchange : Monocytes

    Quantitative, per microliter

    Measured: Day 3

  36. Complete blood count before the plasmapheresis session with single plasma exchange : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  37. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  38. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  39. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Quantitative, per microliter

    Measured: Day 1

  40. Complete blood count after the plasmapheresis session with single plasma exchange : Eosinophils

    Quantitative, per microliter

    Measured: Day 3

  41. Complete blood count before the plasmapheresis session with single plasma exchange : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  42. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  43. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  44. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Quantitative, per microliter

    Measured: Day 1

  45. Complete blood count after the plasmapheresis session with single plasma exchange : Basophils

    Quantitative, per microliter

    Measured: Day 3

  46. Complete blood count before the plasmapheresis session with single plasma exchange : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 0

  47. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 1

  48. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 4

  49. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Quantitative, %

    Measured: Day 1

  50. Complete blood count after the plasmapheresis session with single plasma exchange : Hematocrit

    Quantitative, %

    Measured: Day 3

  51. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Quantitative, %

    Measured: Day 0, Hour 0

  52. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Quantitative, %

    Measured: Day 0, Hour 1

  53. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Quantitative, %

    Measured: Day 0, Hour 4

  54. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Quantitative, %

    Measured: Day 1

  55. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Volume

    Quantitative, %

    Measured: Day 4

  56. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Quantitative, in pg

    Measured: Day 0, Hour 0

  57. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Quantitative, in pg

    Measured: Day 0, Hour 1

  58. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Quantitative, in pg

    Measured: Day 0, Hour 4

  59. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Quantitative, in pg

    Measured: Day 1

  60. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin

    Quantitative, in pg

    Measured: Day 3

  61. Complete blood count before the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Quantitative, in g/L

    Measured: Day 0, Hour 0

  62. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Quantitative, in g/L

    Measured: Day 0, Hour 1

  63. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Quantitative, in g/L

    Measured: Day 0, Hour 4

  64. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Quantitative, in g/L

    Measured: Day 1

  65. Complete blood count after the plasmapheresis session with single plasma exchange : Mean Corpuscular Hemoglobin Concentration

    Quantitative, in g/L

    Measured: Day 3

  66. Serum albumin before the plasmapheresis session with single plasma exchange

    Quantitative, in g/dL

    Measured: Day 0, Hour 0

  67. Serum albumin after the plasmapheresis session with single plasma exchange

    Quantitative, in g/dL

    Measured: Day 0, Hour 1

  68. Serum albumin after the plasmapheresis session with single plasma exchange

    Quantitative, in g/dL

    Measured: Day 0, Hour 4

  69. Serum albumin after the plasmapheresis session with single plasma exchange

    Quantitative, in g/dL

    Measured: Day 1

  70. Serum albumin after the plasmapheresis session with single plasma exchange

    Quantitative, in g/dL

    Measured: Day 3

  71. Prothrombin Time Test and International Normalized Ratio (PT/INR) before the plasmapheresis session with single plasma exchange

    In seconds

    Measured: Day 0, Hour 0

  72. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    In seconds

    Measured: Day 0, Hour 1

  73. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    In seconds

    Measured: Day 0, Hour 4

  74. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    In seconds

    Measured: Day 1

  75. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the plasmapheresis session with single plasma exchange

    In seconds

    Measured: Day 3

  76. Factors VIII, IX, XI and XII before the plasmapheresis session with single plasma exchange

    By 1-stage APTT-based Factor assay, in seconds

    Measured: Day 0, Hour 0

  77. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    By 1-stage APTT-based Factor assay, in seconds

    Measured: Day 0, Hour 1

  78. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    By 1-stage APTT-based Factor assay, in seconds

    Measured: Day 0, Hour 4

  79. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    By 1-stage APTT-based Factor assay, in seconds

    Measured: Day 1

  80. Factors VIII, IX, XI and XII after the plasmapheresis session with single plasma exchange

    By 1-stage APTT-based Factor assay, in seconds

    Measured: Day 3

  81. Factors X, V and II [Prothrombin] before the plasmapheresis session with single plasma exchange

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 0

  82. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 1

  83. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 4

  84. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Prothrombin assay, in seconds

    Measured: Day 1

  85. Factors X, V and II [Prothrombin] after the plasmapheresis session with single plasma exchange

    Prothrombin assay, in seconds

    Measured: Day 3

  86. D-dimers and circulating soluble fibrin monomers before the plasmapheresis session with single plasma exchange

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 0

  87. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 1

  88. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 4

  89. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 1

  90. D-dimers and circulating soluble fibrin monomers after the plasmapheresis session with single plasma exchange

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 3

  91. Platelet function test before the plasmapheresis session with single plasma exchange

    ADP/collagen and adrenalin/collagen cartridges.

    Measured: Day 0, Hour 0

  92. Platelet function test after the plasmapheresis session with single plasma exchange

    ADP/collagen and adrenalin/collagen cartridges.

    Measured: Day 0, Hour 1

  93. Platelet function test after the plasmapheresis session with single plasma exchange

    ADP/collagen and adrenalin/collagen cartridges.

    Measured: Day 0, Hour 4

  94. Platelet function test after the plasmapheresis session with single plasma exchange

    ADP/collagen and adrenalin/collagen cartridges.

    Measured: Day 1

  95. Platelet function test after the plasmapheresis session with single plasma exchange

    ADP/collagen and adrenalin/collagen cartridges.

    Measured: Day 3

  96. von Willebrand factor (vWF) activity - ristocetin cofactor test before the plasmapheresis session with single plasma exchange

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 0

  97. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 1

  98. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 4

  99. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 1

  100. von Willebrand factor (vWF) activity - ristocetin cofactor test after the plasmapheresis session with single plasma exchange

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 3

  101. Thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 0

  102. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 1

  103. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 4

  104. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 1

  105. Thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 3

  106. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

    Measured: Day 0, Hour 0

  107. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

    Measured: Day 0, Hour 1

  108. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

    Measured: Day 0, Hour 4

  109. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

    Measured: Day 1

  110. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange

    Triggered by 5 pM tissue factor with response to purified thrombomodulin (thrombotic exploration version)

    Measured: Day 3

  111. Complete blood count before the double filtration plasmapheresis session : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  112. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  113. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  114. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Quantitative, per microliter

    Measured: Day 1

  115. Complete blood count after the double filtration plasmapheresis session : White blood cells

    Quantitative, per microliter

    Measured: Day 3

  116. Complete blood count before the double filtration plasmapheresis session : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  117. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  118. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  119. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Quantitative, per microliter

    Measured: Day 1

  120. Complete blood count after the double filtration plasmapheresis session : Red blood cells

    Quantitative, per microliter

    Measured: Day 4

  121. Complete blood count before the double filtration plasmapheresis session : Hemoglobin

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  122. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  123. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  124. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Quantitative, per microliter

    Measured: Day 1

  125. Complete blood count after the double filtration plasmapheresis session : Hemoglobin

    Quantitative, per microliter

    Measured: Day 3

  126. Complete blood count before the double filtration plasmapheresis session : Platelets

    Quantitative, %

    Measured: Day 0, Hour 0

  127. Complete blood count after the double filtration plasmapheresis session : Platelets

    Quantitative, %

    Measured: Day 0, Hour 1

  128. Complete blood count after the double filtration plasmapheresis session : Platelets

    Quantitative, %

    Measured: Day 0, Hour 4

  129. Complete blood count after the double filtration plasmapheresis session : Platelets

    Quantitative, %

    Measured: Day 1

  130. Complete blood count after the double filtration plasmapheresis session : Platelets

    Quantitative, %

    Measured: Day 3

  131. Complete blood count before the double filtration plasmapheresis session : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  132. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  133. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  134. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Quantitative, per microliter

    Measured: Day 1

  135. Complete blood count after the double filtration plasmapheresis session : Neutrophils

    Quantitative, per microliter

    Measured: Day 3

  136. Complete blood count before the double filtration plasmapheresis session : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  137. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  138. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  139. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Quantitative, per microliter

    Measured: Day 1

  140. Complete blood count after the double filtration plasmapheresis session : Lymphocytes

    Quantitative, per microliter

    Measured: Day 3

  141. Complete blood count before the double filtration plasmapheresis session : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  142. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  143. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  144. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Quantitative, per microliter

    Measured: Day 1

  145. Complete blood count after the double filtration plasmapheresis session : Monocytes

    Quantitative, per microliter

    Measured: Day 3

  146. Complete blood count before the double filtration plasmapheresis session : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  147. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  148. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  149. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Quantitative, per microliter

    Measured: Day 1

  150. Complete blood count after the double filtration plasmapheresis session : Eosinophils

    Quantitative, per microliter

    Measured: Day 3

  151. Complete blood count before the double filtration plasmapheresis session : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 0

  152. Complete blood count after the double filtration plasmapheresis session : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 1

  153. Complete blood count after the double filtration plasmapheresis session : Basophils

    Quantitative, per microliter

    Measured: Day 0, Hour 4

  154. Complete blood count after the double filtration plasmapheresis session : Basophils

    Quantitative, per microliter

    Measured: Day 1

  155. Complete blood count after the double filtration plasmapheresis session : Basophils

    Quantitative, per microliter

    Measured: Day 3

  156. Complete blood count before the double filtration plasmapheresis session : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 0

  157. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 1

  158. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Quantitative, %

    Measured: Day 0, Hour 4

  159. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Quantitative, %

    Measured: Day 1

  160. Complete blood count after the double filtration plasmapheresis session : Hematocrit

    Quantitative, %

    Measured: Day 3

  161. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Volume

    Quantitative, fL

    Measured: Day 0, Hour 0

  162. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Quantitative, fL

    Measured: Day 0, Hour 1

  163. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Quantitative, fL

    Measured: Day 0, Hour 4

  164. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Quantitative, fL

    Measured: Day 1

  165. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Volume

    Quantitative, fL

    Measured: Day 3

  166. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Quantitative, pg

    Measured: Day 0, Hour 0

  167. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Quantitative, pg

    Measured: Day 0, Hour 1

  168. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Quantitative, pg

    Measured: Day 0, Hour 4

  169. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Quantitative, pg

    Measured: Day 1

  170. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin

    Quantitative, pg

    Measured: Day 3

  171. Complete blood count before the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Quantitative, g/L

    Measured: Day 0, Hour 0

  172. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Quantitative, g/L

    Measured: Day 0, Hour 1

  173. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Quantitative, g/L

    Measured: Day 0, Hour 4

  174. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Quantitative, g/L

    Measured: Day 1

  175. Complete blood count after the double filtration plasmapheresis session : Mean Corpuscular Hemoglobin Concentration

    Quantitative, g/L

    Measured: Day 3

  176. Serum albumin before the double filtration plasmapheresis session.

    Quantitative, g/L

    Measured: Day 0, Hour 0

  177. Serum albumin after the double filtration plasmapheresis session.

    Quantitative, g/L

    Measured: Day 0, Hour 1

  178. Serum albumin after the double filtration plasmapheresis session.

    Quantitative, g/L

    Measured: Day 0, Hour 4

  179. Serum albumin after the double filtration plasmapheresis session.

    Quantitative, g/L

    Measured: Day 1

  180. Serum albumin after the double filtration plasmapheresis session.

    Quantitative, g/L

    Measured: Day 3

  181. Prothrombin Time Test and International Normalized Ratio (PT/INR) before the double filtration plasmapheresis session.

    In seconds

    Measured: Day 0, Hour 0

  182. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    In seconds

    Measured: Day 0, Hour 1

  183. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    In seconds

    Measured: Day 0, Hour 4

  184. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    In seconds

    Measured: Day 1

  185. Prothrombin Time Test and International Normalized Ratio (PT/INR) after the double filtration plasmapheresis session.

    In seconds

    Measured: Day 3

  186. Factors VIII, IX, XI and XII before the double filtration plasmapheresis session.

    1-stage APTT-based Factor assay

    Measured: Day 0, Hour 0

  187. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    1-stage APTT-based Factor assay

    Measured: Day 0, Hour 1

  188. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    1-stage APTT-based Factor assay

    Measured: Day 0, Hour 4

  189. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    1-stage APTT-based Factor assay

    Measured: Day 1

  190. Factors VIII, IX, XI and XII after the double filtration plasmapheresis session.

    1-stage APTT-based Factor assay

    Measured: Day 3

  191. Factors X, V and II [Prothrombin] before the double filtration plasmapheresis session.

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 0

  192. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 1

  193. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Prothrombin assay, in seconds

    Measured: Day 0, Hour 4

  194. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Prothrombin assay, in seconds

    Measured: Day 1

  195. Factors X, V and II [Prothrombin] after the double filtration plasmapheresis session.

    Prothrombin assay, in seconds

    Measured: Day 3

  196. D-dimers and circulating soluble fibrin monomers before the double filtration plasmapheresis session.

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 0

  197. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 1

  198. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 0, Hour 4

  199. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 1

  200. D-dimers and circulating soluble fibrin monomers after the double filtration plasmapheresis session.

    By enzyme-linked immunosorbent assay (ELISA) method

    Measured: Day 3

  201. Platelet function test before the double filtration plasmapheresis session.

    ADP/collagen and adrenalin/collagen cartridges

    Measured: Day 0, Hour 0

  202. Platelet function test after the double filtration plasmapheresis session.

    ADP/collagen and adrenalin/collagen cartridges

    Measured: Day 0, Hour 1

  203. Platelet function test after the double filtration plasmapheresis session.

    ADP/collagen and adrenalin/collagen cartridges

    Measured: Day 0, Hour 4

  204. Platelet function test after the double filtration plasmapheresis session.

    ADP/collagen and adrenalin/collagen cartridges

    Measured: Day 1

  205. Platelet function test after the double filtration plasmapheresis session.

    ADP/collagen and adrenalin/collagen cartridges

    Measured: Day 3

  206. von Willebrand factor (vWF) activity - ristocetin cofactor test before the double filtration plasmapheresis session.

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 0

  207. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 1

  208. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 0, Hour 4

  209. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 1

  210. von Willebrand factor (vWF) activity - ristocetin cofactor test after the double filtration plasmapheresis session.

    Binding to platelet membrane glycoprotein Ib

    Measured: Day 3

  211. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 0

  212. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 1

  213. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 0, Hour 4

  214. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 1

  215. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (hemorrhagic exploration version)

    Triggered by 1 pM tissue factor

    Measured: Day 3

  216. Automated thrombin generation test on Génésia® before the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

    Measured: Day 0, Hour 0

  217. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

    Measured: Day 0, Hour 1

  218. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

    Measured: Day 0, Hour 4

  219. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

    Measured: Day 1

  220. Automated thrombin generation test on Génésia® after the plasmapheresis session with single plasma exchange (thrombotic exploration version)

    Triggered by 5 pM tissue factor with response to purified thrombomodulin

    Measured: Day 3

  221. Plasma Bank

    Storage of unused tube ends

    Measured: Before Day 0, hour 0

  222. Plasma Bank

    Storage of unused tube ends

    Measured: Day 0, hour1

  223. Plasma Bank

    Storage of unused tube ends

    Measured: Day 0, hour 4

  224. Plasma Bank

    Storage of unused tube ends

    Measured: Day 1

  225. Plasma Bank

    Storage of unused tube ends

    Measured: Day 3

  226. Plasma Bank

    Storage of unused tube ends

    Measured: After end of session Day 0, H0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start17 Dec 2024
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Patients being monitored for chronic therapeutic plasmapheresis with regional citrate anticoagulation will be recruited from the Nephrology Department at Nîmes University Hospital. After receiving written informed consent (inclusion visit), patients will be randomized to determine the nature of their first cycle (single plasma exchange or double filtration plasmapheresis. The next cycle will vary accordingly: DFPP if the first cycle was single plasma exchange, and single plasma exchange if the first session was DFPP.
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571552
Sponsor's protocol ID
NIMAO/2023-2/OM01
Acronym
APHERCOAG
Status last verified
Oct 2026
First submitted
23 Aug 2024
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Single Plasma Exchange followed by Double Filtration Plasmapheresis in people with Hyperfibrinogenemia and Hemostatic Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivier MORANNE, Professor (+334.66.68.31.49, olivier.moranne@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of fibrinogen levels before the first plasmapheresis session with single plasma exchange (time frame: Day 0, before the session). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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