EUCTR2014-003978-16-DK进行中（未招募）1 期
Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH). - PRooF-iTH
Section for Transfusion Medicine, Capitol Region Blood Bank0 个研究点开始时间: 2014年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Trauma patient received directly from the scene of the accident AND
- •Age = 18 years AND
- •Initiated order of transfusion of at least one blood component within the 1st hour of arrival AND
- •Predicted to need transfusion package therapy during the initial resuscitation (first 2 hours) AND
- •Consent obtainable from patient or scientific guardians (independent physicians and/or next of kin)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Duration of > 2 hours from arrival at trauma centre OR
- •Anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxiban, apixaban) OR
- •Severe isolated traumatic brain injury OR
- •Moribund patient with devastating injuries and expected to die within one hour of admission OR
- •Withdrawal from active therapy OR
- •Previously within 30 days included in a randomized trial, if known at the time of enrollment OR
- •Known body weight < 55 kg OR
- •Any blood product prior to inclusion
研究者
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