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

Descriptive Information
Brief Title † Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
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)
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 Phase N/A
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Prospective
Primary Outcome Measure † 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
Secondary Outcome Measure † pathogenic nature of anti HPF4 antibodies of IgM and IgA type
Condition † Heparin-induced Thrombocytopenia
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 2700
Start Date † March 2009
Completion Date November 2012
Primary Completion Date November 2012
Eligibility Criteria † 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT00748839
Organization ID 0801016
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Centre Hospitalier Universitaire de Saint Etienne
Collaborators †† Hyphen BioMed
Investigators † Principal Investigator: Bernard TARDY, MD, CHU de Saint-Etienne
Information Provided By
Verification Date November 2012
First Received Date † September 5, 2008
Last Updated Date November 22, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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