EPO-TBI (6-month outcomes)
Trial question
What is the role of EPO in patients with moderate or severe traumatic brain injury?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
17.0% female
83.0% male
N = 606
606 patients (101 female, 505 male).
Inclusion criteria: adult patients admitted to the ICU within 24 hours after non-penetrating moderate or severe traumatic brain injury.
Key exclusion criteria: GCS score of 3 and fixed dilated pupils; history of DVT, PE, or other thromboembolic events; treatment with EPO in the past 30 days; and the first dose of study drug unable to be given within 24 hours of primary injury.
Interventions
N=308 EPO (weekly doses of 40,000 IU of subcutaneous epoetin alfa for a maximum of 3 doses).
N=298 placebo (0.9% sodium chloride weekly for a maximum of 3 doses).
Primary outcome
Severe neurological dysfunction at 6 months, as measured by Extended Glasgow Outcome Scale score of 1-4
44%
45%
45.0 %
33.8 %
22.5 %
11.3 %
0.0 %
Erythropoietin
Placebo
No significant
difference ↔
No significant difference in severe neurological dysfunction at 6 months, as measured by Extended Glasgow Outcome Scale score of 1-4 (44% vs. 45%; RR 0.99, 99% CI 0.83 to 1.18).
Secondary outcomes
No significant difference in death at 6 months (11% vs. 16%; RR 0.68, 95% CI 0.44 to 1.03).
No significant difference in proximal DVT (16% vs. 18%; RR 0.87, 95% CI 0.61 to 1.24).
No significant difference in Extended Glasgow Outcome Scale score of 5-8 (56% vs. 55%; RR 1.01, 95% CI 0.87 to 1.17).
Safety outcomes
No significant difference in adverse events and thrombotic events.
Significant difference in upper limb thrombosis (4% vs. 8%).
Conclusion
In adult patients admitted to the ICU within 24 hours after non-penetrating moderate or severe traumatic brain injury, EPO was not superior to placebo with respect to severe neurological dysfunction at 6 months, as measured by Extended Glasgow Outcome Scale score of 1-4.
Reference
Alistair Nichol, Craig French, Lorraine Little et al. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506.
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