Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical

Completed

• Conditions: Heparin-induced Thrombocytopenia

• Registration Number: NCT00748839
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

Detailed Description

Purpose : To create and validate a score predicting the diagnosis of HIT

Study Timeline

• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-09
• Study Start: 2009-03
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-22
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• all patients presenting, either during or immediately after treatment:

  • thrombocytopenia and/or venous or arterial thrombosis
  • for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study

Exclusion Criteria

• do not possess sufficient clinical data prior to performance of the biological test
• cannot assure follow-up of the patient until normalization of the platelet count

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests	inclusion and 40 days after the inclusion

Secondary Outcome Measures

Name	Time	Method
pathogenic nature of anti HPF4 antibodies of IgM and IgA type	inclusion
new biological test detecting HIT	inclusion

Trial Locations

Locations (27)

ETS de Franche Conté - Laboratoire d'Immuno Hématologie; 🇫🇷 Besançon, France

CHU Cavale Blanche Laboratoire d'Hématologie; 🇫🇷 Brest, France

Laboratoire d'hématologie - Hôpital Louis Pradel; 🇫🇷 Bron, France

Hôpital Antoine Beclère - Laboratoire d'hématologie; 🇫🇷 Clamart, France

Laboratoire d'hématologie - CHU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

HCC Colmar - laboratoire d'hématologie; 🇫🇷 Colmar, France

Laboratoire d'Hématologie - CHU le Bocage; 🇫🇷 Dijon, France

Laboratoire d'hémostase - CCML; 🇫🇷 Le Plessis Robinson, France

Hôpital Cardiologique - Laboratoire d'Hémostase; 🇫🇷 Lille, France

CHU La Timone - Laboratoire Hématologie; 🇫🇷 Marseille, France

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