ACTRN12609000827235
已完成
3 期
A randomised, placebo-controlled trial evaluating the effect of erythropoietin on neurological function in intensive care unit (ICU) patients with traumatic brain injury
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Australian and New Zealand Intensive Care Research Centre
- 入组人数
- 606
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Admitted to ICU with non\-penetrating traumatic brain injury
- •15 to 65 years of age
- •Less than 24 hours since primary traumatic injury
- •Expected to stay greater than or equal to 48 hours
- •Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution
- •Written informed consent from legal surrogate
排除标准
- •Glasgow Coma Score (GCS) is 3 and pupils are fixed and dilated; History of DVT, PE or other thromboembolic event; A chronic hypercoagulable disorder, including known malignancy; Treatment with EPO in the last 30 days; First dose of study drug unable to be given within 24 hours of primary injury; Pregnancy or lactation or 3 months post partum; Uncontrolled hypertension (systolic blood pressure of greater than 200 mm Hg or diastolic blood pressure of greater than 110 mm Hg); Acute myocardial infarct; Expected to die imminently (within 24 hours); Inability to perform lower limb ultrasounds; Known sensitivity to mammalian cell derived products; Hypersensitivity to the active substance or to any of the additives; Pure red cell aplasia (PRCA); End stage renal failure (receives chronic dialysis); Severe pre\-existing physical or mental disability or severe co\-morbidity that may interfere with the assessment of outcome Spinal cord injury; Treatment with any investigational drug within 30 days before enrolment; The treating physician believes it is not in the best interest of the patient to be randomised to this trial.
结局指标
主要结局
未指定
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