Two frequently used anemia treatments did not improve short-term neurocognitive outcomes in patients who experienced a traumatic brain injury, according to results of a randomized trial.
Neither treatment with erythropoietin nor maintaining hemoglobin concentration of at least 10 g/dL offered no benefit in neurological recovery. In fact 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,” Claudia S. Robertson, MD, of the department of neurosurgery at Baylor College of Medicine, and colleagues wrote.
Claudia S. Robertson
Patients who experience severe traumatic brain injury frequently develop anemia, which may contribute to poorer neurological outcomes. Anemia treatment in this patient population often includes administration of erythropoietin or transfusions of packed red blood cells. However, limited data exist on the effects of these treatments, according to background information provided by researchers.
In the current study, Robertson and colleagues used a factorial design to assess whether erythropoietin would improve favorable outcomes by 20%, as well as whether a hemoglobin transfusion of >10 g/dL would improve outcomes without additional complications.
The analysis included 200 patients with closed head injuries who were unable to follow commands. All patients were enrolled on the study within 6 hours of injury at two level 1 trauma centers in the United States between 2006 and 2012.
Researchers initially assigned 102 patients to erythropoietin or placebo. The first 74 patients received their assigned agent in 500 IU/kg doses daily for 3 days, then weekly for 2 more weeks. The remaining 126 patients did not receive doses at 24 hours or 48 hours.
Researchers then assigned 99 patients to a hemoglobin transfusion threshold of 7 g/dL. The other 101 were assigned a threshold of 10 g/dL.
Robertson and colleagues observed no interaction between erythropoietin and hemoglobin transfusion threshold.
Both dosing regiments of erythropoietin were futile, according to researchers.
Researchers reported favorable outcomes of 48.6% (95% CI, 31.4-66) in the first dosing regimen, 29.8% (95% CI, 18.4-43.4%) in the second dosing regimen and 38.2% (95% CI, 28.1-49.1%) in the placebo group.
Results revealed favorable outcome rates of 42.5% for the 7 g/dL hemoglobin transfusion threshold and 33% for the 10 g/dL threshold (95% CI for difference, -.06 to 0.25).
Patients assigned to the 10 g/dL threshold experienced higher incidence of thromboembolic events (21.8% vs. 8.1%; OR=0.32; 95% CI, 0.12-0.79).
Disclosure: The study was supported by grants from National Institute of Neurological Disorders and Stroke, as well as the NIH.