EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, JULY 1, 2014
Media Advisory: To contact Claudia S. Robertson, M.D., call Graciela Gutierrez at 713-798-4710 or email email@example.com.
To place an electronic embedded link to this study in your story This link for the study will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2014.6490
In patients with a traumatic brain injury (TBI), neither the administration of the hormone erythropoietin (EPO) or maintaining a higher hemoglobin concentration through blood transfusion resulted in improved neurological outcome at 6 months, according to a study in the July 2 issue of JAMA. Transfusing at higher hemoglobin concentrations was associated with a higher risk of adverse events.
Patients with severe traumatic brain injury commonly develop anemia. For patients with neurological injury, anemia is a potential cause of secondary injury, which may worsen neurological outcomes. Treatment of anemia may include transfusions of packed red blood cells or administration of erythropoietin. There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold (if the hemoglobin concentration drops below a certain level, a transfusion is performed) after a TBI, according to background information in the article.
Claudia S. Robertson, M.D., of the Baylor College of Medicine, Houston, and colleagues conducted a randomized clinical trial that included 200 patients (erythropoietin, n = 102; placebo, n = 98) with a closed head injury at neurosurgical intensive care units in two U.S. level I trauma centers between May 2006 and August 2012. Patients were enrolled within 6 hours of injury and had to be unable to follow commands after initial stabilization. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (n = 74). There were 99 patients assigned to a hemoglobin transfusion threshold of 7 g/dL and 101 patients assigned to 10 g/dL.
In the placebo group, 34 patients (38.2 percent) recovered to a favorable outcome (defined as good recovery and moderate disability, as measured by a functional assessment inventory) compared with 17 patients (48.6 percent) in the erythropoietin 1 group (first dosing regimen) and 17 patients (29.8 percent) in the erythropoietin 2 group (second dosing regimen). Thirty-seven patients (42.5 percent) assigned to the transfusion threshold of 7 g/dL recovered to a favorable outcome compared with 31 patients (33.0 percent) assigned to the transfusion threshold of 10 g/dL.
There was a higher incidence of thromboembolic events for the transfusion threshold of 10 g/dL (21.8 percent) vs (8.1 percent) for the threshold of 7 g/dL.
“Among patients with closed head injury, neither the administration of erythropoietin nor maintaining hemoglobin concentration of at least 10 g/dL resulted in improved neurological outcome at 6 months. These findings do not support either approach in patients with traumatic brain injury,” the authors conclude.
(doi:10.1001/jama.2014.6490; Available pre-embargo to the media at http://media.jamanetwork.com)
Editor’s Note: This study was supported by a grant from the National Institute of Neurological Disorders and Stroke. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.
# # #