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

• ClinicalTrials.gov Identifier: NCT01648556
• Recruitment Status: Unknown
• First Posted: July 24, 2012
• Last Update Posted: August 2, 2016
• Sponsor: Centre Hospitalier Universitaire, Amiens
• Information provided by (Responsible Party): Centre Hospitalier Universitaire, Amiens

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.

Condition or disease	Intervention/treatment	Phase
Purpura Thrombopenic	Other: Blood tests and bone marrow biopsy repeated	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: September 2012
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. dosage of the TPO [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ]
2. 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) ]
3. The isotopic lifetime of platelet [ Time Frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion) ]
   < or > 3.5 days
4. The test in corticoids by the prednisone per os [ Time Frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion) ]
   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

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Contacts

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

Locations

France

CHU Amiens; 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

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT01648556 History of Changes
• Other Study ID Numbers: PI2011_843_0002
• First Posted: July 24, 2012
• Last Update Posted: August 2, 2016
• Last Verified: August 2016

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; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Signs and Symptoms; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Immune System Diseases; Prednisone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents