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Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial.

AbstractIMPORTANCE:
There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury.
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 = 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.
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.
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 = .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 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.
AuthorsClaudia 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, Paul Swank
JournalJAMA (JAMA) Vol. 312 Issue 1 Pg. 36-47 (Jul 02 2014) ISSN: 1538-3598 [Electronic] United States
PMID25058216 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
Chemical References
  • Hemoglobins
  • Erythropoietin
Topics
  • Adult
  • Anemia (complications, etiology, therapy)
  • Brain Injuries (complications, therapy)
  • Erythrocyte Transfusion (adverse effects, methods)
  • Erythropoietin (administration & dosage)
  • Female
  • Glasgow Outcome Scale
  • Hemoglobins (analysis)
  • Humans
  • Male
  • Middle Aged
  • Neurologic Examination
  • Persistent Vegetative State
  • Reference Values
  • Severity of Illness Index
  • Thromboembolism (chemically induced)
  • Treatment Outcome
  • Young Adult

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