Clinical Trial: Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis
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 Summary: Purpose : To create and validate a score predicting the diagnosis of HIT
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Current Primary Outcome: 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 [ Time Frame: inclusion and 40 days after the inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- pathogenic nature of anti HPF4 antibodies of IgM and IgA type [ Time Frame: inclusion ]
- new biological test detecting HIT [ Time Frame: inclusion ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Saint Etienne
Dates:
Date Received: September 5, 2008
Date Started: March 2009
Date Completion:
Last Updated: November 22, 2012
Last Verified: November 2012
