EUCTR2011-005235-22-FI进行中（未招募）不适用
A randomised, placebo-controlled trial of erythropoietin in ICU patients with traumatic brain injury:Erythropoietin in Traumatic Brain Injury - EPO-TBI
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 606
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 non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) TBI admitted to the ICU who:
- •Are >= 15 to <= 65 years of age
- •Are < 24 hours since primary traumatic injury
- •Are expected to stay >= 48 hours
- •Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution
- •Have written informed consent from legal surrogate
- •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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •GCS = 3 and fixed dilated pupils
- •History of DVT, PE or other thromboembolic event
- •Chronic hypercoagulable disorder, including known malignancy
- •EPO in the last 30 day
- •Pregnancy or lactation or 3 months post partum
- •Uncontrolled hypertension
- •Acute myocardial infarct within the past 12 months
- •Past history of epilepsy with seizures in past 3 months
- •Expected to die imminently
- •Inability to perform lower limb ultrasounds
- •lKnown sensitivity to mammalian cell derived products
- •Hypersensitivity
- •Pure red cell aplasia
- •End stage renal failure
- •Severe pre-existing physical or mental disability or severe co-morbidity
- •Treatment with any investigational drug within 30 days before enrolment
- •Not in the best interest of the patient
研究者
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