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临床试验/ISRCTN40935649
ISRCTN40935649已完成4 期

Inflammatory response in major injury and recombinant human erythropoietin

Abertawe Bro Morgannwg University Health Board0 个研究点目标入组 400 人开始时间: 2016年3月17日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged between 18-60 years
  • 2. Blunt trauma patients admitted to ITU
  • 3. Injury severity score (ISS) at least 16
  • 4. ITU stay expected to last at least 3 days

排除标准

  • 1. Pregnancy (an admission pregnancy test is routine in all female trauma patients who are of child-bearing age)
  • 2. Presence of a severe isolated traumatic brain injury
  • 3. Presence of any blood-borne infections e.g. HIV, hepatitis B or C.
  • 4. Presence of any known malignancies
  • 5. Presence of not been consented by a personal legal representative or a professional legal representative if the former is not available
  • 6. Are already participating in another clinical trial
  • 7. Presence of a contra-indication to thromboprophylaxis
  • 8. Presence of contra-indications for rhEPO:
  • 8.1. Uncontrolled hypertension
  • 8.2. Known sensitivity to mammalian cell derived products
  • 8.3. Hypersensitivity to the active substance or to any of the excipients
  • 8.4. Severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident
  • 8.5. Patients who have developed Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin
  • 8.6. A history of thrombo-embolic vascular (TVE) events

研究者

发起方
Abertawe Bro Morgannwg University Health Board

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