Purpura ThrombopenicPREDI-PTINCT01648556
Research of Predictive Factors to Immune Thrombopenic Purpura
A study testing Blood tests and bone marrow biopsy repeated in people with Purpura Thrombopenic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Purpura Thrombopenic
- What is being tested?
- Blood tests and bone marrow biopsy repeated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2013to 28 Dec 2022
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rate of platelet < 100 G/l for less than 12 months ,
- age = ou > 60 years,
- haemoglobin > ou = 12 g / dl at the woman, > ou = 13 g/dl at the man,
- polymorphonuclear neutrophil > ou = 1.7 G/l,
- monocytes < ou= 1 G/l,
- lymphocytes < ou = à 4 G/l,
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- VGM < 100 fL, blood film normal,
- informed consent,
- expectation of life > 6 months
Who cannot join
- hepatomegaly,
- splenomegaly,
- hepatic abnormality,
- blood coagulation abnormality,
- antecedent of auto-immune disease,
- drug thrombopenia,
- HIV, VHB or VHC positive,
- antecedent of malicious tumor in the 5 years before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly
It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.
Read the detailed description
It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.
The principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly.
The secondary endpoints are :
- to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD
- to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years. 200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years.
In every visit, will be realized a clinical examination, a blood film, a haemogram.
If the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded.
- Conditions
- Purpura Thrombopenic
- Being tested
- Blood tests and bone marrow biopsy repeated
- Keywords
- Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy
- Medical subject headings
- Purpura, Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood tests and bone marrow biopsy repeatedOther
Also called The test in corticoids by the prednisone per os
Blood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet.
The test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal.
| Study group | Role | What they receive |
|---|---|---|
| patients with a thrombopenia isolated | Other | Patients of 60 years old and more presenting a thrombopenia isolated with a rate of platelet < 100 G/l Blood tests and bone marrow biopsy repeated Receives: Other: Blood tests and bone marrow biopsy repeated |
What is being measured
The primary outcome is the main question the study is designed to answer.
the result of cytogenetics medullary
the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.
Measured: two years after inclusion
Secondary outcomes (4)
dosage of the TPO
Measured: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
the result to the antibodies antiplatelet (positive or negative) for MAIPA
Measured: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
The isotopic lifetime of platelet
< or > 3.5 days
Measured: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
The test in corticoids by the prednisone per os
1 mg / kg / day for 3 weeks The therapeutic test is considered as positive if a number of platelets is > 50 G/l with at least a doubling of the platelet rate before treatment
Measured: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start15 Jan 2013
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura ThrombopenicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, Henri Mondor University Hospital, Hôpital Jean Verdier, Abbeville Hospital Center, Centre Hospitalier Intercommunal de Compiègne-Noyon, CHRU BREST, CHRU LILLE, University Hospital, Angers, Centre Hospitalier Universitaire de Besancon, University Hospital, Caen, Centre Hospitalier Universitaire de Nice, Rennes University Hospital, University Hospital, Toulouse, GROUPE HOSPITALIER INSTITUT CATHOLIQUE
- Responsible party
- Sponsor
- Investigators
- Jean Pierre MD MAROLLEAU, phD, Principal investigator, CHU AMIENSmathilde HUNAULT BERGER, Ph D, Principal investigator, University Hospital, AngersNADINE MAGY BERTRAND, PH D, Principal investigator, Centre Hospitalier Universitaire de BesanconOlivier FAIN, PH D, Principal investigator, HOPITAL JEAN VERDIER, BONDYBRIGITTE PAN PETESCH, D, Principal investigator, CHU BRESTMICHEL LEPORRIER, PH D, Principal investigator, University Hospital, CaenBERTRAND GODEAU, PH D, Principal investigator, CHU CRETEILPHILIPPE BIERLING, PH D, Principal investigator, EFS IVRY SUR SEINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648556
- Sponsor's protocol ID
- PI2011_843_0002
- Acronym
- PREDI-PTI
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2012
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly
- ClinicalTrials.gov ID
- NCT01648556
- Acronym / sponsor ID
- PREDI-PTI / PI2011_843_0002
- Conditions
- Purpura Thrombopenic
- Keywords
- Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, Henri Mondor University Hospital, Hôpital Jean Verdier, Abbeville Hospital Center, Centre Hospitalier Intercommunal de Compiègne-Noyon, CHRU BREST, CHRU LILLE, University Hospital, Angers, Centre Hospitalier Universitaire de Besancon, University Hospital, Caen, Centre Hospitalier Universitaire de Nice, Rennes University Hospital, University Hospital, Toulouse, GROUPE HOSPITALIER INSTITUT CATHOLIQUE
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 24 Jul 2012 (estimated)
- 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.
It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.
Detailed description
It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.
The principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly.
The secondary endpoints are :
- to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD
- to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years. 200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years.
In every visit, will be realized a clinical examination, a blood film, a haemogram.
If the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a thrombopenia isolated | Other | Other: Blood tests and bone marrow biopsy repeatedPatients of 60 years old and more presenting a thrombopenia isolated with a rate of platelet < 100 G/l Blood tests and bone marrow biopsy repeated |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Rate of platelet < 100 G/l for less than 12 months ,
- age = ou > 60 years,
- haemoglobin > ou = 12 g / dl at the woman, > ou = 13 g/dl at the man,
- polymorphonuclear neutrophil > ou = 1.7 G/l,
- monocytes < ou= 1 G/l,
Key exclusion criteria (8 listed)
- hepatomegaly,
- splenomegaly,
- hepatic abnormality,
- blood coagulation abnormality,
- antecedent of auto-immune disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood tests and bone marrow biopsy repeatedAlso: The test in corticoids by the prednisone per osBlood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet. The test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal. | Other | patients with a thrombopenia isolated |
Primary outcome
the result of cytogenetics medullary
Time frame: two years after inclusion
the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.
4 secondary outcomes
dosage of the TPO
Time frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
the result to the antibodies antiplatelet (positive or negative) for MAIPA
Time frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
The isotopic lifetime of platelet
Time frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)
The test in corticoids by the prednisone per os
Time frame: EVERY 4 MONTHS (followed every 4 months during two years after the 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 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Jean Pierre MD MAROLLEAU, phD principal investigator
CHU AMIENS
mathilde HUNAULT BERGER, Ph D principal investigator
University Hospital, Angers
NADINE MAGY BERTRAND, PH D principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood tests and bone marrow biopsy repeated in people with Purpura Thrombopenic, run by Centre Hospitalier Universitaire, Amiens 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 9 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: finished, as of the sponsor's last update on 12 Mar 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?
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?
the result of cytogenetics medullary (time frame: two years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.