Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
研究概览
简要总结
Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).
详细描述
This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH).
Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT).
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge.
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •trauma-surgical patient
- •consent given
- •minimum age 18
- •expected inpatient period at least 7 days
- •need for thrombosis prophylaxis with heparin
排除标准
- •intolerance of one of the study drugs
- •malignancy with life expectancy < 3 months
- •pregnancy/lactation
- •drug or alcohol abuse
- •fibrinolytic therapy
- •need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry
- •participation in another clinical trial within 30 days prior to intended inclusion
结局指标
主要结局
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
次要结局
- Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
- TECs during 3 months following discharge in relation to heparin received and HIT-antibody status