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

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.

Study Overview

• Status: Unknown
• Conditions: Purpura Thrombopenic
• Intervention / Treatment: Other: Blood tests and bone marrow biopsy repeated

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JEAN PIERRE MAROLLEAU; Phone Number: 00 33 33 45 59 14; Email: marolleau.jean-pierre@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens
    • Contact: Jean Pierre MAROLLEAU, MD-PhD
    • Principal Investigator: Jean-Pierre MAROLLEAU, MD-PhD
    • Sub-Investigator: Bruno ROYER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the result of cytogenetics medullary	the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.	two years after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dosage of the TPO		EVERY 4 MONTHS (followed every four months during two years apres inclusion)
the result to the antibodies antiplatelet (positive or negative) for MAIPA		EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)
The isotopic lifetime of platelet	< or > 3.5 days	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	EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)

Collaborators and Investigators

• Sponsor: 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 Besançon; Principal Investigator: Olivier FAIN, PH D, Hôpital 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 Créteil; 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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: bone marrow biopsy; Myelodysplasic syndrome; Purpura thrombopenic; Medullary cytogenetics
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: PI2011_843_0002