The HIT-TRAP Trial
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
研究概览
详细说明
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.
研究类型
注册
阶段
- 第四阶段
联系人和位置
学习地点
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Greifswald、德国、17489
- Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- trauma-surgical patient
- consent given
- minimum age 18
- expected inpatient period at least 7 days
- need for thrombosis prophylaxis with heparin
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
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Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
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次要结果测量
结果测量 |
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Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
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TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
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合作者和调查者
合作者
调查人员
- 首席研究员：Andreas Greinacher, Prof. Dr.、Ernst-Moritz-Arndt University Greifswald, Germany
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.