NCT01648556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

January 15, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

July 20, 2012

Last Update Submit

March 10, 2026

Conditions

Purpura Thrombopenic

Keywords

Purpura thrombopenicMedullary cytogeneticsMyelodysplasic syndromebone marrow biopsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    EVERY 4 MONTHS (followed every four months during two years apres inclusion)

  • The test in corticoids by the prednisone per os

    EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)

Study Arms (1)

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

Other: Blood tests and bone marrow biopsy repeated

Interventions

Blood tests and bone marrow biopsy repeatedOTHER

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.

Also known as: The test in corticoids by the prednisone per os
patients with a thrombopenia isolated

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • hepatomegaly,
  • splenomegaly,
  • hepatic abnormality,
  • blood coagulation abnormality,
  • antecedent of auto-immune disease,
  • drug thrombopenia,
  • HIV, VHB or VHC positive,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

PurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

January 15, 2013

Primary Completion

December 28, 2022

Study Completion

December 28, 2022

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)