Inclusion | Patients with non-penetrating moderate (Glasgow Coma Score (GCS) 9–12) or severe (GCS 3–8) traumatic brain injury admitted to an ICU who: |
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1. Are ≥15 to ≤65 years of age* | |
2. Are <24 hours since primary traumatic injury | |
3. Are expected to stay ≥48 hours | |
4. Have a haemoglobin not exceeding the upper limit of the applicable normal reference range in clinical use at the treating institution** | |
5. Have written informed consent from legal surrogate | |
Exclusion | Patients are excluded from the study if any of the following criteria apply#: |
1. GCS = 3 and fixed dilated pupils | |
2. History of deep vein thrombosis, pulmonary embolism or other thromboembolic event | |
3. A chronic hypercoagulable disorder, including known malignancy | |
4. Treatment with erythropoietin in the last 30 days | |
5. First dose of study drug unable to be given within 24 hours of primary injury | |
6. Pregnancy or lactation or 3 months post-partum | |
7. Uncontrolled hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) | |
8. Acute myocardial infarct within the past 12 months | |
9. Past history of epilepsy with seizures in past 3 months | |
10. Expected to die imminently (<24 hours) | |
11. Inability to perform lower limb ultrasounds | |
12. Known sensitivity to mammalian cell-derived products | |
13. Hypersensitivity to the active substance or to any of the additives | |
14. Pure red cell aplasia | |
15. End-stage renal failure (receives chronic dialysis) | |
16. Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome | |
17. Spinal cord injury | |
18. Treatment with any investigational drug within 30 days before enrolment | |
19. The treating physician believes it is not in the best interests of the patient to be randomised to this trial |