Inflammatory response in major injury and recovery - erythropoieti
- Conditions
- Major Trauma (Injury Severity Score 16+)Injury, Occupational Diseases, PoisoningMajor Trauma
- Registration Number
- ISRCTN40935649
- Lead Sponsor
- Abertawe Bro Morgannwg University Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Multiple organ failaure is monitored using the Denver multiple organ failure score at baseline, day 3 and then daily until discharge from ITU, mortality or 30 days.
- Secondary Outcome Measures
Name Time Method