SAHARA
Trial question
What is the role of liberal transfusion strategy in patients with aneurysmal subarachnoid hemorrhage and anemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
82.0% female
18.0% male
N = 732
732 patients (598 female, 134 male).
Inclusion criteria: patients with aneurysmal subarachnoid hemorrhage and anemia.
Key exclusion criteria: nonaneurysmal subarachnoid hemorrhage; active bleeding leading to hemodynamic instability; contraindications or known objections to blood transfusion.
Interventions
N=366 liberal strategy (mandatory transfusion at a hemoglobin level ≤ 10 g/dL).
N=366 restrictive strategy (optional transfusion at a hemoglobin level ≤ 8 g/dL).
Primary outcome
Unfavorable neurologic outcome at 12 months
33.5%
37.7%
37.7 %
28.3 %
18.9 %
9.4 %
0.0 %
Liberal
strategy
Restrictive
strategy
No significant
difference ↔
No significant difference in unfavorable neurologic outcome at 12 months (33.5% vs. 37.7%; RR 0.88, 95% CI 0.72 to 1.09).
Secondary outcomes
No significant difference in mean Functional Independence Measure score at 12 months (82.8 points vs. 79.8 points; MD 3.01, 95% CI -5.49 to 11.51).
No significant difference in mean EuroQol 5-dimension, 5-level utility index score at 12 months (0.5 points vs. 0.5 points; MD 0.02, 95% CI -0.04 to 0.09).
No significant difference in mean VAS score at 12 months (52.1 points vs. 50 points; MD 2.08, 95% CI -3.76 to 7.93).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with aneurysmal subarachnoid hemorrhage and anemia, liberal strategy was not superior to restrictive strategy with respect to unfavorable neurologic outcome at 12 months.
Reference
Shane W English, Anthony Delaney, Dean A Fergusson et al. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2024 Dec 9. Online ahead of print.
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