Status:

COMPLETED

Anomalies of Dense Platelet Granules

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

Assistance Publique Hopitaux De Marseille

CENTRE DE REFERENCE DES MALADIES HEMORRAGIQUES CONSTITUTIONNELLES

Conditions:

Spontaneous Induced Unexplained Haemorrhagic

Eligibility:

All Genders

2+ years

Brief Summary

The study aims to know the overall prevalence of granular deficits and their breakdown by type (anomaly of number, content or secretion) in a population of patients with hemorrhagic symptomatology aft...

Detailed Description

Patients will be recruited during the exploration visit (v0) or the confirmation/typing visit (v1) according to their follow-up. * Exploration visit (v0): inclusion of patients without prior platelet...

Eligibility Criteria

Inclusion

  • Adult or child patient ≥ 2 years
  • Having a hemorrhagic score ISTH \> 3 for men, \> 5 for women and \> 2 for children.
  • With no abnormal coagulation (defined by normal TP and TCK or activity ≥ 50% of FII, FV, FVII, FX, FVIII, FIX, FXI)
  • no deficiency of Willebrand factor (defined by a cofactor activity with Ristoctin (VWF: RCo \< 50%))
  • no a known major thrombocytopenia/thrombopathy linked to a deficiency of one of the major platelet receptors
  • Information of the patient and/or his legal representative present

Exclusion

  • Inability or refusal of compliance with research requirements
  • Thrombocytopenia \< 100 G/L
  • Treatments interfering with platelet functions within 10 days prior to inclusion
  • Malignant hemopathy

Key Trial Info

Start Date :

December 9 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 21 2023

Estimated Enrollment :

166 Patients enrolled

Trial Details

Trial ID

NCT04095715

Start Date

December 9 2019

End Date

February 21 2023

Last Update

October 30 2023

Active Locations (1)

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1

Hôpital Necker Enfants Malades - AP-HP

Paris, France, 75015

Anomalies of Dense Platelet Granules | DecenTrialz