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Julia", "lastName": "Hannay" }, { "creatorType": "author", "firstName": "José-Miguel", "lastName": "Yamal" }, { "creatorType": "author", "firstName": "Shankar", "lastName": "Gopinath" }, { "creatorType": "author", "firstName": "J. Clay", "lastName": "Goodman" }, { "creatorType": "author", "firstName": "Barbara C.", "lastName": "Tilley" }, { "creatorType": "author", "name": "Epo Severe TBI Trial Investigators" }, { "creatorType": "author", "firstName": "Athena", "lastName": "Baldwin" }, { "creatorType": "author", "firstName": "Lucia", "lastName": "Rivera Lara" }, { "creatorType": "author", "firstName": "Hector", "lastName": "Saucedo-Crespo" }, { "creatorType": "author", "firstName": "Osama", "lastName": "Ahmed" }, { "creatorType": "author", "firstName": "Santhosh", "lastName": "Sadasivan" }, { "creatorType": "author", "firstName": "Luciano", "lastName": "Ponce" }, { "creatorType": "author", "firstName": "Jovanny", "lastName": "Cruz-Navarro" }, { "creatorType": "author", "firstName": "Hazem", "lastName": "Shahin" }, { "creatorType": "author", "firstName": "Imoigele P.", "lastName": "Aisiku" }, { "creatorType": "author", "firstName": "Pratik", "lastName": "Doshi" }, { "creatorType": "author", "firstName": "Alex", "lastName": "Valadka" }, { "creatorType": "author", "firstName": "Leslie", "lastName": "Neipert" }, { "creatorType": "author", "firstName": "Jace M.", "lastName": "Waguspack" }, { "creatorType": "author", "firstName": "M. Laura", "lastName": "Rubin" }, { "creatorType": "author", "firstName": "Julia S.", "lastName": "Benoit" }, { "creatorType": "author", "firstName": "Paul", "lastName": "Swank" } ], "abstractNote": "IMPORTANCE: There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury.\nOBJECTIVE: To compare the effects of erythropoietin and 2 hemoglobin transfusion thresholds (7 and 10 g/dL) on neurological recovery after traumatic brain injury.\nDESIGN, 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.\nINTERVENTIONS: Intravenous erythropoietin (500 IU/kg per dose) or saline. Transfusion threshold maintained with packed red blood cells.\nMAIN 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.\nRESULTS: 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).\nCONCLUSIONS 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.\nTRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00313716.", "publicationTitle": "JAMA: the journal of the American Medical Association", "publisher": "", "place": "", "date": "Jul 2, 2014", "volume": "312", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "36-47", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "JAMA", "DOI": "10.1001/jama.2014.6490", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "1538-3598", "archive": "", "archiveLocation": "", "shortTitle": "Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury", "language": "eng", "libraryCatalog": "NCBI PubMed", "callNumber": "", "rights": "", "extra": "PMID: 25058216 \nPMCID: PMC4113910", "tags": [ { "tag": "Adult", "type": 1 }, { "tag": "Anemia", "type": 1 }, { "tag": "Brain Injuries", "type": 1 }, { "tag": "Erythrocyte Transfusion", "type": 1 }, { "tag": "Erythropoietin", "type": 1 }, { "tag": "Female", "type": 1 }, { "tag": "Glasgow Outcome Scale", "type": 1 }, { "tag": "Hemoglobins", "type": 1 }, { "tag": "Humans", "type": 1 }, { "tag": "Male", "type": 1 }, { "tag": "Middle Aged", "type": 1 }, { "tag": "Neurologic Examination", "type": 1 }, { "tag": "Persistent Vegetative State", "type": 1 }, { "tag": "Reference Values", "type": 1 }, { "tag": "Severity of Illness Index", "type": 1 }, { "tag": "Thromboembolism", "type": 1 }, { "tag": "Treatment Outcome", "type": 1 }, { "tag": "Young Adult", "type": 1 } ], "collections": [], "relations": {}, "dateAdded": "2014-09-09T16:16:03Z", "dateModified": "2014-09-09T16:16:03Z" } } ]