EPO-TBI (long-term follow-up)
Trial question
What is the role of recombinant EPO in patients with moderate-to-severe traumatic brain injury?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 356
356 patients (66 female, 290 male).
Inclusion criteria: patients receiving treatment in the ICU with moderate-to-severe traumatic brain injury based on GCS score.
Key exclusion criteria: unsurvivable neurological injury; high risk of VTE; greater risk due to trial drug exposure.
Interventions
N=175 EPO (weekly doses of 40,000 IU of subcutaneous epoetin alfa).
N=181 placebo (0.9% sodium chloride weekly).
Primary outcome
Survival
5.7 years
5.3 years
5.7 years
4.3 years
2.9 years
1.4 years
0.0 years
Erythropoietin
Placebo
No significant
difference ↔
No significant difference in survival (5.7 years vs. 5.3 years; HR 0.73, 95% CI 0.47 to 1.14).
Secondary outcomes
No significant difference in good functional outcome (63% vs. 55%; RR 1.14, 95% CI 0.96 to 1.35).
Significant increase in good functional outcome sliding scale (64% vs. 52%; RR 1.23, 95% CI 1.03 to 1.47).
Borderline significant increase in EuroQol Group 5-Dimension Self-Report Questionnaire score (0.776 points vs. 0.713 points; MD 0.07, 95% CI 0 to 0.15).
Conclusion
In patients receiving treatment in the ICU with moderate-to-severe traumatic brain injury based on GCS score, EPO was not superior to placebo with respect to survival.
Reference
Markus B Skrifvars, Nora Luethi, Michael Bailey et al. The effect of recombinant erythropoietin on long-term outcome after moderate-to-severe traumatic brain injury. Intensive Care Med. 2023 Jul;49(7):831-839.
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