EUCTR2020-003388-24-FI进行中（未招募）1 期
A randomised, double-blind, placebo-controlled trial of erythropoietin alfa versus placebo in mechanically ventilated critically ill patients following traumatic injury - EPO-TRAUMA
niversity College Dublin0 个研究点目标入组 2,500 人开始时间: 2021年11月15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
- 2,500
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
- •Patients with trauma admitted to the ICU who:
- •a) Are = 18 to = 75 years of age
- •b) Are < 24 hours since primary traumatic injury
- •c) Are invasively mechanically ventilated
- •d) Are expected to stay in the ICU = 48 hours
- •e) Have a haemoglobin not exceeding the upper limit of the applicable
- •normal (ULN) reference range in clinical use at the treating institution
- •f) Have informed consent from legal surrogate according to local law
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 2500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •Patients will be excluded from the study if any of the following criteria
- •a) GCS = 3 and fixed dilated pupils
- •b) History of DVT, PE or other thromboembolic event
- •c) A chronic hypercoagulable disorder, including known malignancy
- •d) Treatment with EPO in the last 30 days
- •e) First dose of study drug unable to be given within 24 hours of primary injury
- •f) Pregnancy or lactation or 3 months post-partum
- •g) Expected to die imminently (< 24 hours)
- •h) Known sensitivity to mammalian cell derived products
- •i) Known contraindication to epoetin alfa
- •j) End stage renal failure (receives chronic dialysis)
- •k) Severe pre-existing physical or mental disability or severe comorbidity
- •that may interfere with the assessment of outcome
- •l) The treating physician believes it is not in the best interest of the patient to be randomised to this trial
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