Abstract

Objectives: Recombinant erythropoietin (EPO) administered during intensive care is one possible treatment method for patients with traumatic brain injury that may increase short-term survival. Its effect on long-term outcome including functional outcome is unknown. Methods: We conducted a long-term follow up of patients included in the multi-center erythropoietin in traumatic brain injury (TBI) trial (Clinical Trials.gov NCT00987454) conducted between 2010 and 2014. We invited patients treated in all countries except France to participate in a follow-up and evaluated survival and functional outcome with the Glasgow outcome scale extended (GOSE) with categories 5 to 8 defined as good outcome. We categorized TBI severity with the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT-TBI) model and calculated adjusted odds ratios (OR) and 95% confidence intervals (CI). Results: Of 603 patients included in the original trial, 371 were included in the follow-up at a median of six years from injury (interquartile range 3-8 years). Out of 185 patients treated with EPO, 140 (76%) were alive and 110 (60%) had good outcome. The corresponding numbers for the 180 placebo patients were 136 (73%) and 100 (53%) (p=0.57, p=0.27). A multivariable model adjusting for the IMPACT severity provided comparable results the effect of EPO for survival (OR 1.3 95% CI 0.8-2.2, p=0.31)) and good outcome (OR 1.5 95% 0.9-2.4, p=0.09). Conclusions: EPO did not decrease mortality or improve outcome but the limited sample size does not rule out clinically meaningful effects suggesting the need for a larger study.

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