TY  - JOUR
PY  - 2014//
TI  - Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial
JO  - JAMA journal of the American Medical Association
A1  - Robertson, Claudia S.
A1  - Hannay, H. Julia
A1  - Yamal, José-Miguel
A1  - Gopinath, Shankar
A1  - Goodman, J. Clay
A1  - Tilley, Barbara C.
A1  - Baldwin, Athena
A1  - Rivera Lara, Lucia
A1  - Saucedo-Crespo, Hector
A1  - Ahmed, Osama
A1  - Sadasivan, Santhosh
A1  - Ponce, Luciano
A1  - Cruz-Navarro, Jovanny
A1  - Shahin, Hazem
A1  - Aisiku, Imoigele P.
A1  - Doshi, Pratik
A1  - Valadka, Alex
A1  - Neipert, Leslie
A1  - Waguspack, Jace M.
A1  - Rubin, M. Laura
A1  - Benoit, Julia S.
A1  - Swank, Paul
SP  - 36
EP  - 47
VL  - 312
IS  - 1
N2  - IMPORTANCE: There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury. <br><br>OBJECTIVE: To 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 PARTICIPANTS: Randomized clinical trial of 200 patients (erythropoietin, n DESIGN, SETTING, AND PARTICIPANTS:  = 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 erythropoiet DESIGN, SETTING, AND PARTICIPANTS: in 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) a DESIGN, SETTING, AND PARTICIPANTS: nd 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. INTERVENTIONS: Intravenous erythropoietin (500 IU/kg per dose) or saline. Transfusion threshold maintained with packed red blood cells. MAIN OUTCOMES AND MEASURES: Glasgow Outcome Scale score dichotomized as favorable (good recovery and moderate disability) or unfavorable (severe disability, vegetative, or dead) at 6 months postinjury. <br><br>RESULTS: There 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 RESULTS:  = .13; second dosing regimen: 17/57 [29.8%; 95% CI, 18.4% to 43.4%], P  RESULTS: < RESULTS:  .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% RESULTS: ] 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). <br><br>CONCLUSIONS AND RELEVANCE: In 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 REGISTRATION: clinicaltrials.gov Identifier: NCT00313716.<p />  <p>Language: en</p>
LA  - en
SN  - 0098-7484
UR  - http://dx.doi.org/10.1001/jama.2014.6490
ID  - ref1
ER  -