EUCTR2011-003669-14-IT进行中(未招募)1 期
Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial. - CRASH-3 [Version 1.0]
ondon School Of Hygiene and Tropical Medicine0 个研究点目标入组 12,737 人开始时间: 2014年2月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 12,737
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult (16 years and older) with traumatic brain injury (TBI)
- •who are within 8 hours of injury
- •with any intracranial bleeding on CT scan OR GCS =12 if no scan available, and
- •who have no significant extra cranial bleeding (needing immediate blood transfusion)
- •The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use tranexamic acid in a particular patient with TBI
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
- •Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy
研究者
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不适用
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