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

Primary Purpose

Purpura Thrombopenic

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood tests and bone marrow biopsy repeated
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Purpura Thrombopenic focused on measuring Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with a thrombopenia isolated

Arm Description

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

Outcomes

Primary Outcome Measures

the result of cytogenetics medullary
the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.

Secondary Outcome Measures

dosage of the TPO
the result to the antibodies antiplatelet (positive or negative) for MAIPA
The isotopic lifetime of platelet
< or > 3.5 days
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

Full Information

First Posted
July 20, 2012
Last Updated
August 1, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01648556
Brief Title
Research of Predictive Factors to Immune Thrombopenic Purpura
Acronym
PREDI-PTI
Official Title
Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura Thrombopenic
Keywords
Purpura thrombopenic, Medullary cytogenetics, Myelodysplasic syndrome, bone marrow biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with a thrombopenia isolated
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood tests and bone marrow biopsy repeated
Other Intervention Name(s)
The test in corticoids by the prednisone per os
Intervention Description
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.
Primary Outcome Measure Information:
Title
the result of cytogenetics medullary
Description
the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.
Time Frame
two years after inclusion
Secondary Outcome Measure Information:
Title
dosage of the TPO
Time Frame
EVERY 4 MONTHS (followed every four months during two years apres inclusion)
Title
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)
Title
The isotopic lifetime of platelet
Description
< or > 3.5 days
Time Frame
EVERY 4 MONTHS (followed every four months during two years apres inclusion)
Title
The test in corticoids by the prednisone per os
Description
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
Time Frame
EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEAN PIERRE MAROLLEAU
Phone
00 33 33 45 59 14
Email
marolleau.jean-pierre@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Pierre MD MAROLLEAU, phD
Organizational Affiliation
CHU AMIENS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
mathilde HUNAULT BERGER, Ph D
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NADINE MAGY BERTRAND, PH D
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier FAIN, PH D
Organizational Affiliation
HOPITAL JEAN VERDIER, BONDY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BRIGITTE PAN PETESCH, D
Organizational Affiliation
CHU BREST
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MICHEL LEPORRIER, PH D
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BERTRAND GODEAU, PH D
Organizational Affiliation
CHU CRETEIL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PHILIPPE BIERLING, PH D
Organizational Affiliation
EFS IVRY SUR SEINE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LOUIS TERRIOU, PH D
Organizational Affiliation
CHRU LILLE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JEAN MARC DURAND, PH D
Organizational Affiliation
LA CONCEPTION MARSEILLE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Pierre MAROLLEAU, MD-PhD
First Name & Middle Initial & Last Name & Degree
Jean-Pierre MAROLLEAU, MD-PhD
First Name & Middle Initial & Last Name & Degree
Bruno ROYER, MD

12. IPD Sharing Statement

Learn more about this trial

Research of Predictive Factors to Immune Thrombopenic Purpura

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