Research of Predictive Factors to Immune Thrombopenic Purpura (PREDI-PTI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01648556
First received: July 20, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Purpura Thrombopenic
Other: Blood tests and bone marrow biopsy repeated

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • the result of cytogenetics medullary [ Time Frame: two years after inclusion ] [ Designated as safety issue: No ]
    the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.


Secondary Outcome Measures:
  • dosage of the TPO [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • The isotopic lifetime of platelet [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ] [ Designated as safety issue: No ]
    < or > 3.5 days

  • The test in corticoids by the prednisone per os [ Time Frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patients with a thrombopenia isolated
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
Other: Blood tests and bone marrow biopsy repeated

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.

Other Name: The test in corticoids by the prednisone per os

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
  • VGM < 100 fL, blood film normal,
  • informed consent,
  • expectation of life > 6 months

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648556

Contacts
Contact: JEAN PIERRE MAROLLEAU 00 33 33 45 59 14 marolleau.jean-pierre@chu-amiens.fr

Locations
France
CHU Amiens Not yet recruiting
Amiens, France, 80000
Contact: Jean Pierre MAROLLEAU, MD-PhD         
Principal Investigator: Jean-Pierre MAROLLEAU, MD-PhD         
Sub-Investigator: Bruno ROYER, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean Pierre MD MAROLLEAU, phD CHU AMIENS
Principal Investigator: mathilde HUNAULT BERGER, Ph D University Hospital, Angers
Principal Investigator: NADINE MAGY BERTRAND, PH D Centre Hospitalier Universitaire de Besancon
Principal Investigator: Olivier FAIN, PH D HOPITAL JEAN VERDIER, BONDY
Principal Investigator: BRIGITTE PAN PETESCH, D CHU BREST
Principal Investigator: MICHEL LEPORRIER, PH D University Hospital, Caen
Principal Investigator: BERTRAND GODEAU, PH D CHU CRETEIL
Principal Investigator: PHILIPPE BIERLING, PH D EFS IVRY SUR SEINE
Principal Investigator: LOUIS TERRIOU, PH D CHRU LILLE
Principal Investigator: JEAN MARC DURAND, PH D LA CONCEPTION MARSEILLE
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01648556     History of Changes
Other Study ID Numbers: PI 2011_843_0002
Study First Received: July 20, 2012
Last Updated: July 20, 2012
Health Authority: France : ANSM French health product safety Agency

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Purpura thrombopenic
Medullary cytogenetics
Myelodysplasic syndrome
bone marrow biopsy

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on October 23, 2014