Patients Without a Medical History of Thrombosis or HemorrhageEVIGENCT05422157
Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
An observational study of Patients Without a Medical History of Thrombosis or Hemorrhage and Hemophilic Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been performed in laboratories by semi-automated techniques, sometimes using in-house reagents, which led to a high variability and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Without a Medical History of Thrombosis or Hemorrhage, Hemophilic Patient, Patient With FV Leiden Mutation
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 10 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patient taken care of at the Clermont-Ferrand University Hospital
Who may be able to join
- Major patient, male or female
- Affiliated to a social security system
- In capacity to express informed consent to participate in research
- Control group: 5 men, 5 women without oral contraception, 5 women with oral contraception and apparently healthy with a respect to hemostasis (no history of thrombosis or significant bleeding on examination)
- Hemophilia groups: - 5 hemophiliacs A (treated or untreated), with predictable FVIII:C levels between < 1% and 40%.
- 5 hemophiliacs B (treated or not), with predictable FIX:C levels between < 1% and 40%.
Show all 15Show fewer
- FV Leiden group: 5 patients known to be heterozygous or homozygous for the R506Q mutation of the F5 gene (the so-called "Factor V Leiden" mutation)
- Cirrhosis group: - 5 patients with Child-Pugh A
- 5 patients with Child-Pugh B
- 5 patients with Child-Pugh C
- Anticoagulation group: - 5 patients on anti-vitamin K therapy for at least 1 month, with INR between 2 and 4
- 5 patients on apixaban for at least 1 week
- 5 patients on rivaroxaban for at least 1 week
- 5 patients on dabigatran for at least 1 week
- 5 patients on low molecular weight heparin for at least 1 day
Who cannot join
- Refusal to participate
- Patient under protective measures (guardianship, curatorship) or under judicial protection
- Minor patients
- Moderate to end-stage renal failure
- Proven inflammatory state/infectious syndrome (body temperature > 38°C and/or clinical signs suggestive of infection) during or in the week prior to collection, at the discretion of the investigator
- Transfusion in the week prior to collection
Show all 22Show fewer
- Pregnant or breastfeeding woman
- Contraception by estrogen-progestin, except for the control group concerned
- Anticoagulation of less than one week, except for the anticoagulation group
- Control group: - Presence of drug treatment known to interfere with hemostasis
- Presence of a pathology known to interfere with hemostasis such as renal or hepatic insufficiency
- Presence of a history of venous thromboembolic disease or diagnosed hemorrhagic disease
- Predicted inclusion hemoglobin level < 7g/L
- Hemophilic groups: - Presence of anti FVIII or anti FIX inhibitors
- Treatment with emicizumab
- Predicted inclusion hemoglobin level < 7g/L
- FV Leiden group: - Presence of anticoagulant therapy at the time of collection
- Predicted baseline hemoglobin < 7g/L
- Anticoagulation group: - Anticoagulant therapy not stabilized as determined by the practitioner
- Presence of a therapeutic relaunch in progress
- Hemoglobin at predicted inclusion < 9-10g/L
- Cirrhosis group: Predicted inclusion hemoglobin level < 7g/L
Trial locations and contacts
1 site in 1 country.
About this study
The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been performed in laboratories by semi-automated techniques, sometimes using in-house reagents, which led to a high variability and did not allow multicenter studies. Recently, an automated device for the evaluation of thrombin generation has been placed on the market (ST-Genesia), allowing a better standardization of the technique. In order to allow multicenter studies, which are essential for the routine positioning of the thrombin generation test, the inter-center variability must be evaluated, as a priority, in the pathologies for which the test is routinely positioned.
Thrombin generation (TG) assays are long-established research tools in hemostasis. They are used for both fundamental and clinical research, but a multiplicity of test methodologies limits the large adoption of TG due to the variability of results despite the attempts to standardize practices.
Read more
Several publications already exist to evaluate its analytical performances, and thereby demonstrate that the test automation also allows its democratization to reach acceptable performances It also enables the evaluation of the device in various indications such as, for example, the evaluation of the effect of direct oral anticoagulants or the evaluation of the risk of breast cancer recurrence.
The confirmation of these anterior results allows further clinical investigations in larger cohorts. However, the absence of interchangeability between the two systems indicates that the results will need to be more rugged through multicenter studies on ST Genesia.
Read the detailed description
A preliminary step in the development of multi-center protocols is to confirm that inter-center variability is acceptable on ST Genesia, and even more acceptable than it was on Calibrated Automated Thrombogram (CAT). Since the variability of the results can be attributed to analytical, pre-analytical and inter-individual biological variabilities, it has been agreed that the evaluation that we will conduct will focus only on the analytical variability and will therefore be carried out on the same samples, collected and prepared in the sponsoring center of the study, and distributed in the form of frozen aliquots to the different co-investigating centers.
The evaluation of this inter-center variability of this new device will allow, if satisfactory, to propose multicenter studies. These are essential in order to position the thrombin generation test in routine in these various promising clinical contexts.
- Conditions
- Patients Without a Medical History of Thrombosis or Hemorrhage, Hemophilic Patient, Patient With FV Leiden Mutation, Patient With Cirrhosis, Patient on Anticoagulant
- Keywords
- Coagulation, Variability, Hemostasis, Thrombin generation
- Medical subject headings
- Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. | |
| Hemophilia | No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. | |
| FV Leiden | No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. | |
| Cirrhosis | No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. | |
| Anticoagulation | No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the inter-center analytical variability of the thrombin generation measurement on ST Genesia, on different types of normo-, hypo- or hyper-coagulable samples.
Assessing the analytical variability of the thrombin generation measurement on ST Genesia, compared to that observed on CAT, on different groups of patients
Measured: at the time of inclusion
Secondary outcomes (2)
Assessment of inter-center analytical variability on ST Genesia related to different reagent lots, for centers with multiple reagent lots.
Measure of the thrombin generation in absolute value
Measured: at the time of inclusion
Comparing the analytical variability between centers observed on the same samples on the reference system, the Calibrated Automated Thrombogram, for centers also equipped with this device
Investigate the differences between thrombin generation measurements on CAT and ST genesia
Measured: at the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start7 Sep 2022
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Patients Without a Medical History of Thrombosis or HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostica Stago
- Responsible party
- Sponsor
- Investigators
- Aurélien Lebreton, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422157
- Sponsor's protocol ID
- RNI 2021 LEBRETON 3 (EVIGE)
- Other IDs
- 2021-A01971-40
- Acronym
- EVIGE
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hemker HC. Recollections on thrombin generation. J Thromb Haemost. 2008 Feb;6(2):219-26. doi: 10.1111/j.1538-7836.2008.02864.x. Epub 2007 Dec 10.
PubMed 18088345Baglin T. The measurement and application of thrombin generation. Br J Haematol. 2005 Sep;130(5):653-61. doi: 10.1111/j.1365-2141.2005.05612.x.
PubMed 16115120de Laat-Kremers RMW, Ninivaggi M, Devreese KMJ, de Laat B. Towards standardization of thrombin generation assays: Inventory of thrombin generation methods based on results of an International Society of Thrombosis and Haemostasis Scientific Standardization Committee survey. J Thromb Haemost. 2020 Aug;18(8):1893-1899. doi: 10.1111/jth.14863. Epub 2020 Jun 3.
PubMed 32319140Dargaud Y, Wolberg AS, Luddington R, Regnault V, Spronk H, Baglin T, Lecompte T, Ten Cate H, Negrier C. Evaluation of a standardized protocol for thrombin generation measurement using the calibrated automated thrombogram: an international multicentre study. Thromb Res. 2012 Dec;130(6):929-34. doi: 10.1016/j.thromres.2012.07.017. Epub 2012 Aug 19.
PubMed 22909826Perrin J, Depasse F, Lecompte T; French-speaking CAT group and under the aegis of GEHT; French-speaking CAT group (all in France unless otherwise stated):; French-speaking CAT group all in France unless otherwise stated. Large external quality assessment survey on thrombin generation with CAT: further evidence for the usefulness of normalisation with an external reference plasma. Thromb Res. 2015 Jul;136(1):125-30. doi: 10.1016/j.thromres.2014.12.015. Epub 2014 Dec 24.
PubMed 25563679Calzavarini S, Brodard J, Quarroz C, Maire L, Nutzi R, Jankovic J, Rotondo LC, Giabbani E, Fiedler GM, Nagler M, Angelillo-Scherrer A. Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability. Res Pract Thromb Haemost. 2019 Jul 18;3(4):758-768. doi: 10.1002/rth2.12238. eCollection 2019 Oct.
PubMed 31624796Douxfils J, Morimont L, Bouvy C, de Saint-Hubert M, Devalet B, Devroye C, Dincq AS, Dogne JM, Guldenpfennig M, Baudar J, Larock AS, Lessire S, Mullier F. Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. J Thromb Haemost. 2019 Aug;17(8):1273-1287. doi: 10.1111/jth.14470. Epub 2019 May 31.
PubMed 31063645Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.
PubMed 33369212Mori F, Genuardo C, Nannizzi S, Farina C. Intra- and interassay variations of two thrombin generation methods. Int J Lab Hematol. 2021 Aug;43(4):O218-O220. doi: 10.1111/ijlh.13524. Epub 2021 Mar 24. No abstract available.
PubMed 33759358Metze M, Pfrepper C, Kloter T, Stobe S, Siegemund R, Siegemund T, Edel E, Laufs U, Petros S. Inhibition of thrombin generation 12 hours after intake of direct oral anticoagulants. Res Pract Thromb Haemost. 2020 Apr 23;4(4):610-618. doi: 10.1002/rth2.12332. eCollection 2020 May.
PubMed 32548560Gomez-Rosas P, Pesenti M, Verzeroli C, Giaccherini C, Russo L, Sarmiento R, Masci G, Celio L, Minelli M, Gamba S, Tartari CJ, Tondini C, Giuliani F, Petrelli F, D'Alessio A, Gasparini G, Labianca R, Santoro A, De Braud F, Marchetti M, Falanga A; HYPERCAN Investigators. Validation of the Role of Thrombin Generation Potential by a Fully Automated System in the Identification of Breast Cancer Patients at High Risk of Disease Recurrence. TH Open. 2021 Feb 10;5(1):e56-e65. doi: 10.1055/s-0040-1722609. eCollection 2021 Jan.
PubMed 33585786Talon L, Sinegre T, Lecompte T, Pereira B, Massoulie S, Abergel A, Lebreton A. Hypercoagulability (thrombin generation) in patients with cirrhosis is detected with ST-Genesia. J Thromb Haemost. 2020 Sep;18(9):2177-2190. doi: 10.1111/jth.14963. Epub 2020 Jul 23.
PubMed 32558351
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
- ClinicalTrials.gov ID
- NCT05422157
- Acronym / sponsor ID
- EVIGE / RNI 2021 LEBRETON 3 (EVIGE)
- Conditions
- Patients Without a Medical History of Thrombosis or Hemorrhage, Hemophilic Patient, Patient With FV Leiden Mutation, Patient With Cirrhosis, Patient on Anticoagulant
- Keywords
- Coagulation, Variability, Hemostasis, Thrombin generation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Diagnostica Stago
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been performed in laboratories by semi-automated techniques, sometimes using in-house reagents, which led to a high variability and did not allow multicenter studies. Recently, an automated device for the evaluation of thrombin generation has been placed on the market (ST-Genesia), allowing a better standardization of the technique. In order to allow multicenter studies, which are essential for the routine positioning of the thrombin generation test, the inter-center variability must be evaluated, as a priority, in the pathologies for which the test is routinely positioned.
Thrombin generation (TG) assays are long-established research tools in hemostasis. They are used for both fundamental and clinical research, but a multiplicity of test methodologies limits the large adoption of TG due to the variability of results despite the attempts to standardize practices.
Several publications already exist to evaluate its analytical performances, and thereby demonstrate that the test automation also allows its democratization to reach acceptable performances It also enables the evaluation of the device in various indications such as, for example, the evaluation of the effect of direct oral anticoagulants or the evaluation of the risk of breast cancer recurrence.
The confirmation of these anterior results allows further clinical investigations in larger cohorts. However, the absence of interchangeability between the two systems indicates that the results will need to be more rugged through multicenter studies on ST Genesia.
Detailed description
A preliminary step in the development of multi-center protocols is to confirm that inter-center variability is acceptable on ST Genesia, and even more acceptable than it was on Calibrated Automated Thrombogram (CAT). Since the variability of the results can be attributed to analytical, pre-analytical and inter-individual biological variabilities, it has been agreed that the evaluation that we will conduct will focus only on the analytical variability and will therefore be carried out on the same samples, collected and prepared in the sponsoring center of the study, and distributed in the form of frozen aliquots to the different co-investigating centers.
The evaluation of this inter-center variability of this new device will allow, if satisfactory, to propose multicenter studies. These are essential in order to position the thrombin generation test in routine in these various promising clinical contexts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | –No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
| Hemophilia | – | –No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
| FV Leiden | – | –No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
| Cirrhosis | – | –No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
| Anticoagulation | – | –No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient taken care of at the Clermont-Ferrand University Hospital
Key inclusion criteria (15 listed)
- Major patient, male or female
- Affiliated to a social security system
- In capacity to express informed consent to participate in research
- Control group: 5 men, 5 women without oral contraception, 5 women with oral contraception and apparently healthy with a respect to hemostasis (no history of thrombosis or significant bleeding on examination)
- Hemophilia groups: - 5 hemophiliacs A (treated or untreated), with predictable FVIII:C levels between < 1% and 40%.
Key exclusion criteria (22 listed)
- Refusal to participate
- Patient under protective measures (guardianship, curatorship) or under judicial protection
- Minor patients
- Moderate to end-stage renal failure
- Proven inflammatory state/infectious syndrome (body temperature > 38°C and/or clinical signs suggestive of infection) during or in the week prior to collection, at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the inter-center analytical variability of the thrombin generation measurement on ST Genesia, on different types of normo-, hypo- or hyper-coagulable samples.
Time frame: at the time of inclusion
Assessing the analytical variability of the thrombin generation measurement on ST Genesia, compared to that observed on CAT, on different groups of patients
2 secondary outcomes
Assessment of inter-center analytical variability on ST Genesia related to different reagent lots, for centers with multiple reagent lots.
Time frame: at the time of inclusion
Comparing the analytical variability between centers observed on the same samples on the reference system, the Calibrated Automated Thrombogram, for centers also equipped with this device
Time frame: at the time of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 18088345Hemker HC. Recollections on thrombin generation. J Thromb Haemost. 2008 Feb;6(2):219-26. doi: 10.1111/j.1538-7836.2008.02864.x. Epub 2007 Dec 10.
- Background: PubMed 16115120Baglin T. The measurement and application of thrombin generation. Br J Haematol. 2005 Sep;130(5):653-61. doi: 10.1111/j.1365-2141.2005.05612.x.
- Background: PubMed 32319140de Laat-Kremers RMW, Ninivaggi M, Devreese KMJ, de Laat B. Towards standardization of thrombin generation assays: Inventory of thrombin generation methods based on results of an International Society of Thrombosis and Haemostasis Scientific Standardization Committee survey. J Thromb Haemost. 2020 Aug;18(8):1893-1899. doi: 10.1111/jth.14863. Epub 2020 Jun 3.
- Background: PubMed 22909826Dargaud Y, Wolberg AS, Luddington R, Regnault V, Spronk H, Baglin T, Lecompte T, Ten Cate H, Negrier C. Evaluation of a standardized protocol for thrombin generation measurement using the calibrated automated thrombogram: an international multicentre study. Thromb Res. 2012 Dec;130(6):929-34. doi: 10.1016/j.thromres.2012.07.017. Epub 2012 Aug 19.
- Background: PubMed 25563679Perrin J, Depasse F, Lecompte T; French-speaking CAT group and under the aegis of GEHT; French-speaking CAT group (all in France unless otherwise stated):; French-speaking CAT group all in France unless otherwise stated. Large external quality assessment survey on thrombin generation with CAT: further evidence for the usefulness of normalisation with an external reference plasma. Thromb Res. 2015 Jul;136(1):125-30. doi: 10.1016/j.thromres.2014.12.015. Epub 2014 Dec 24.
- Background: PubMed 31624796Calzavarini S, Brodard J, Quarroz C, Maire L, Nutzi R, Jankovic J, Rotondo LC, Giabbani E, Fiedler GM, Nagler M, Angelillo-Scherrer A. Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability. Res Pract Thromb Haemost. 2019 Jul 18;3(4):758-768. doi: 10.1002/rth2.12238. eCollection 2019 Oct.
- Background: PubMed 31063645Douxfils J, Morimont L, Bouvy C, de Saint-Hubert M, Devalet B, Devroye C, Dincq AS, Dogne JM, Guldenpfennig M, Baudar J, Larock AS, Lessire S, Mullier F. Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. J Thromb Haemost. 2019 Aug;17(8):1273-1287. doi: 10.1111/jth.14470. Epub 2019 May 31.
- Background: PubMed 33369212Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.
- Background: PubMed 33759358Mori F, Genuardo C, Nannizzi S, Farina C. Intra- and interassay variations of two thrombin generation methods. Int J Lab Hematol. 2021 Aug;43(4):O218-O220. doi: 10.1111/ijlh.13524. Epub 2021 Mar 24. No abstract available.
- Background: PubMed 32548560Metze M, Pfrepper C, Kloter T, Stobe S, Siegemund R, Siegemund T, Edel E, Laufs U, Petros S. Inhibition of thrombin generation 12 hours after intake of direct oral anticoagulants. Res Pract Thromb Haemost. 2020 Apr 23;4(4):610-618. doi: 10.1002/rth2.12332. eCollection 2020 May.
- Background: PubMed 33585786Gomez-Rosas P, Pesenti M, Verzeroli C, Giaccherini C, Russo L, Sarmiento R, Masci G, Celio L, Minelli M, Gamba S, Tartari CJ, Tondini C, Giuliani F, Petrelli F, D'Alessio A, Gasparini G, Labianca R, Santoro A, De Braud F, Marchetti M, Falanga A; HYPERCAN Investigators. Validation of the Role of Thrombin Generation Potential by a Fully Automated System in the Identification of Breast Cancer Patients at High Risk of Disease Recurrence. TH Open. 2021 Feb 10;5(1):e56-e65. doi: 10.1055/s-0040-1722609. eCollection 2021 Jan.
- Background: PubMed 32558351Talon L, Sinegre T, Lecompte T, Pereira B, Massoulie S, Abergel A, Lebreton A. Hypercoagulability (thrombin generation) in patients with cirrhosis is detected with ST-Genesia. J Thromb Haemost. 2020 Sep;18(9):2177-2190. doi: 10.1111/jth.14963. Epub 2020 Jul 23.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien Lebreton principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Without a Medical History of Thrombosis or Hemorrhage and Hemophilic Patient, run by University Hospital, Clermont-Ferrand 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 15 inclusion and 22 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: finished, as of the sponsor's last update on 12 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the inter-center analytical variability of the thrombin generation measurement on ST Genesia, on different types of normo-, hypo- or hyper-coagulable samples. (time frame: at the time of inclusion). 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 NCT05422157, which also lists 12 linked publications.
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 12 Jul 2024.