Erythropoietin in Traumatic Brain Injury (EPO-TBI)

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group; Monash University; National Health and Medical Research Council, Australia
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• GCS = 3 and fixed dilated pupils

• History of DVT, PE or other thromboembolic event

• A chronic hypercoagulable disorder, including known malignancy

• Treatment with EPO in the last 30 days

• First dose of study drug unable to be given within 24 hours of primary injury

• Pregnancy or lactation or 3 months post partum

• Uncontrolled hypertension (systolic blood pressure of >200 mm Hg or diastolic blood pressure of >110 mm Hg)

• Acute myocardial infarct

• Expected to die imminently (< 24 hours)

• Inability to perform lower limb ultrasounds

• Known sensitivity to mammalian cell derived products

• Hypersensitivity to the active substance or to any of the additives

• Pure red cell aplasia (PRCA)

• End stage renal failure (receives chronic dialysis)

• Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome

• Spinal cord injury

• Treatment with any investigational drug within 30 days before enrolment

• The treating physician believes it is not in the best interest of the patient to be randomised to this trial