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

Heparin-induced Thrombocytopenia Clinical Trial

— Score-TIH  

Official title:

Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748839
• Other study ID #: 0801016
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: November 22, 2012
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
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	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	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	G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran	Paris
France	Hématologie Biologique - Hôpital Tenon,	Paris
France	Hôpital BICHAT - Service d'hématologie immunologie	Paris
France	Hôpital Européen Georges Pompidou - Service Hématologie Biologique A	Paris
France	Hôpital Necker Enfants Malades -Laboratoire d'Hématologie	Paris
France	Hôpital Cardiologique - CHU Bordeaux	Pessac
France	Laboratoire central d'hématologie - Hôpital R. DEBRE	Reims
France	CHU de ROUEN	Rouen
France	Laboratoire d'hématologie	Saint-Etienne
France	Service d'Urgence et de Réanimation	Saint-Etienne
France	CHU Strasbourg Hautepierre Laboratoire d'Hématologie	Strasbourg
France	CMC Foch Laboratoire d'hémostase	Suresnes
France	Hopital Purpan - Laboratoire d'hématologie	Toulouse
France	CHU Trousseau - CTH - Service d'Hématologie Hémostase	Tours

Sponsors (7)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Association Française des centres régionaux de Pharmacovigilance, CIC-EC de Saint-Etienne, Groupe d'étude sur l'Hémostase et la Thrombose, Hyphen BioMed, Laboratoires Organon, Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	pathogenic nature of anti HPF4 antibodies of IgM and IgA type		inclusion	No
Secondary	new biological test detecting HIT		inclusion	No