• Claudia S Robertson, H Julia Hannay, José-Miguel Yamal, Shankar Gopinath, J Clay Goodman, Barbara C Tilley, Epo Severe TBI Trial Investigators, Athena Baldwin, Lucia Rivera Lara, Hector Saucedo-Crespo, Osama Ahmed, Santhosh Sadasivan, Luciano Ponce, Jovanny Cruz-Navarro, Hazem Shahin, Imoigele P Aisiku, Pratik Doshi, Alex Valadka, Leslie Neipert, Jace M Waguspack, M Laura Rubin, Julia S Benoit, and Paul Swank.
• Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.
• JAMA. 2014 Jul 2; 312 (1): 36-47.

ImportanceThere is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury.ObjectiveTo compare the effects of erythropoietin and 2 hemoglobin transfusion thresholds (7 and 10 g/dL) on neurological recovery after traumatic brain injury.Design, Setting, And ParticipantsRandomized clinical trial of 200 patients (erythropoietin, n = 102; placebo, n = 98) with closed head injury who were unable to follow commands and were enrolled within 6 hours of injury at neurosurgical intensive care units in 2 US level I trauma centers between May 2006 and August 2012. The study used a factorial design to test whether erythropoietin would fail to improve favorable outcomes by 20% and whether a hemoglobin transfusion threshold of greater than 10 g/dL would increase favorable outcomes without increasing complications. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (n = 74) and then the 24- and 48-hour doses were stopped for the remainder of the patients (n = 126). There were 99 patients assigned to a hemoglobin transfusion threshold of 7 g/dL and 101 patients assigned to 10 g/dL.InterventionsIntravenous erythropoietin (500 IU/kg per dose) or saline. Transfusion threshold maintained with packed red blood cells.Main Outcomes And MeasuresGlasgow Outcome Scale score dichotomized as favorable (good recovery and moderate disability) or unfavorable (severe disability, vegetative, or dead) at 6 months postinjury.ResultsThere was no interaction between erythropoietin and hemoglobin transfusion threshold. Compared with placebo (favorable outcome rate: 34/89 [38.2%; 95% CI, 28.1% to 49.1%]), both erythropoietin groups were futile (first dosing regimen: 17/35 [48.6%; 95% CI, 31.4% to 66.0%], P = .13; second dosing regimen: 17/57 [29.8%; 95% CI, 18.4% to 43.4%], P < .001). Favorable outcome rates were 37/87 (42.5%) for the hemoglobin transfusion threshold of 7 g/dL and 31/94 (33.0%) for 10 g/dL (95% CI for the difference, -0.06 to 0.25, P = .28). There was a higher incidence of thromboembolic events for the transfusion threshold of 10 g/dL (22/101 [21.8%] vs 8/99 [8.1%] for the threshold of 7 g/dL, odds ratio, 0.32 [95% CI, 0.12 to 0.79], P = .009).Conclusions And RelevanceIn patients with closed head injury, neither the administration of erythropoietin nor maintaining hemoglobin concentration of greater than 10 g/dL resulted in improved neurological outcome at 6 months. The transfusion threshold of 10 g/dL was associated with a higher incidence of adverse events. These findings do not support either approach in this setting.Trial Registrationclinicaltrials.gov Identifier: NCT00313716.

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