A randomised, placebo-controlled trial evaluating the effect of erythropoietin on neurological function in intensive care unit (ICU) patients with traumatic brain injury

Australian and New Zealand Intensive Care Research Centre0 个研究点目标入组 606 人开始时间: 2009年9月22日最近更新: 2020年1月13日

试验速览

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•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

•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.

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