Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
- Conditions
- Heparin-induced Thrombocytopenia
- Registration Number
- NCT00748839
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2700
-
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
- 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)
CHU Trousseau - CTH - Service d'Hématologie Hémostase
🇫🇷Tours, France
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
HCC Colmar - laboratoire d'hématologie
🇫🇷Colmar, France
Hôpital Antoine Beclère - Laboratoire d'hématologie
🇫🇷Clamart, France
Laboratoire d'hématologie - CHU de Clermont Ferrand
🇫🇷Clermont Ferrand, 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
Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
🇫🇷Montpellier, France
Hématologie biologique - CHU Nancy
🇫🇷Nancy, France
HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
🇫🇷Nantes, France
Hématologie Biologique - Hôpital Tenon,
🇫🇷Paris, France
Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
🇫🇷Paris, France
Hôpital BICHAT - Service d'hématologie immunologie
🇫🇷Paris, France
G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
🇫🇷Paris, France
Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
🇫🇷Paris, France
Hôpital Cardiologique - CHU Bordeaux
🇫🇷Pessac, France
Laboratoire central d'hématologie - Hôpital R. DEBRE
🇫🇷Reims, France
CHU de ROUEN
🇫🇷Rouen, France
CMC Foch Laboratoire d'hémostase
🇫🇷Suresnes, France
Laboratoire d'hématologie
🇫🇷Saint-Etienne, France
Service d'Urgence et de Réanimation
🇫🇷Saint-Etienne, France
CHU Strasbourg Hautepierre Laboratoire d'Hématologie
🇫🇷Strasbourg, France
Hopital Purpan - Laboratoire d'hématologie
🇫🇷Toulouse, France