EUCTR2019-000936-24-NO进行中（未招募）1 期
Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in trauma patients with haemorrhagic shock induced endotheliopathy – a multicentre randomized, placebo-controlled, blinded, investigator-initiated trial - SHINE-TRAUMA
Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital0 个研究点目标入组 220 人开始时间: 2019年10月2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
- 入组人数
- 220
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
- •Age = 18 years
- •Present with clinical signs of hemorrhagic shock (defined by systolic blood pressure <90 mmHg or use of pre-hospital blood transfusion).
- •Activation of internal massive transfusion protocol and initiation of the first transfusion after admission.
- •Randomised within 5 hours of injury and 5 hour of admission to the ED of the participating trial site.
- •Consent is provided on behalf of incapacitated patients by Scientific Guardian
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Withdrawal from active therapy
- •Known hypersensitivity to Ilomedin®.
- •Pregnancy (non-pregnancy confirmed by patient having a negative urine- or blood hCG or being postmenopausal defined as females beyond 60 years old or at the investigators discretion)
- •Known severe heart failure (NYHA class IV)
- •Suspected acute coronary syndrome
- •Estimated weight < 40 kg
研究者
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