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临床试验/EUCTR2011-005235-22-IE
EUCTR2011-005235-22-IE进行中(未招募)不适用

Erythropoietin in Traumatic Brain Injury (EPO-TBI) - EPO-TBI

MONASH UNIVERSITY0 个研究点目标入组 606 人开始时间: 2013年1月10日最近更新:
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
  • Not in the best interest of the patient

研究者

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