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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,700
- 试验地点
- 27
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Purpose : To create and validate a score predicting the diagnosis of HIT
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: inclusion and 40 days after the inclusion
次要结局
- pathogenic nature of anti HPF4 antibodies of IgM and IgA type(inclusion)
- new biological test detecting HIT(inclusion)