A new randomized controlled trial refutes the theory that either Epogen or liberal transfusions will improve neurologic outcome in patients with traumatic brain injury.
Head trauma occurs in 1.5 million Americans annually, at a cost of more than $56 billion. Erythropoietin (EPO) has potential as a neuroprotective agent in the treatment of traumatic brain injury (TBI; Surg Neurol 2009; 71:527). Hemoglobin transfusion is often used out of concern about the harm of low hemoglobin during trauma, despite some evidence of harm from transfusion. This is a randomized clinical trial comparing the effects of EPO and two hemoglobin transfusion thresholds (7 and 10 g/dL) on neurologic recovery after TBI. Two hundred patients met eligibility criteria and were randomized: 49 to hemoglobin transfusion threshold of 7 g/dL plus EPO, 50 to a hemoglobin threshold of 7 g/dL plus placebo, 53 to hemoglobin threshold of 10 g/dL plus EPO, and 48 to hemoglobin threshold of 10 g/dL plus placebo The EPO regimen was reduced from three doses to one dose partway through the study period. Participants had closed head injury, were unable to follow commands, and were enrolled within 6 hours after injury at neurosurgical intensive care units in two U.S. level I trauma centers. The primary outcome was Glasgow Outcome Scale score at 6 months.
Compared with placebo (favorable outcome rate, 38.2%), both EPO groups were futile (first dosing regimen, 48.6%; second dosing regimen, 29.8%). Favorable outcome rates were 42.5% for the hemoglobin transfusion threshold of 7 g/dL and 33.0% for 10 g/dL, a nonsignificant difference.
Robertson CS et al. Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: A randomized clinical trial. JAMA 2014 Jul 2; 312:36. Link.