Major Trauma (Injury Severity Score 16+) Injury, Occupational Diseases, Poisoning Major Trauma
Conditions
Interventions
Participants are randomly allocated to one of two groups.
Intervention group: Participants receive rhEPO (40,000 units) via subcutaneous injection on day 1, 8 and 15 post admission, w
Sponsors
Abertawe Bro Morgannwg University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Treatment plan (surgery and/or interventional radiology) is recorded at baseline 2. Length of ITU stay is determined at 30 days, time of discharge from ITU or death 3. Critical care support required is measured by mode and duration of mechanical ventilation and inotrope infusion daily throughout ITU stay 4. Length of hospital stay is determined from patient notes at 30 days, discharge or death 5. Thromboembolic vascular events (TVE) rate is determined from reviewing patient notes at 30 days, discharge or death 6. The inflammatory response to injury is measured using the Systemic Inflammatory Response clinical score (SIRS) calculated daily and using cytokine and cellular protein assays at on blood samples taken daily, while on ITU 7. Presence of Persistent Inflammation/Catabolism syndrome (PICS) is calculated from clinical observations and protein assays from day 10, only in those remaining on ITU at that point 8. Leukocyte progenitor proliferation/differentiation in bone marrow aspirates is assessed using flow cytometry and colony forming unit assays obtained on day 2 while on ITU, and subsequently in those requiring pelvic fracture surgery 9. Mitochondrial respiratory function is measured using bioenergetic profile assays on blood obtained daily until while on ITU | — |
Countries
United Kingdom
Outcome results
None listed