Antifibrinolytic treatment in subarachnoid hemorrhage: a randomized placebo-controlled trial. STAR Study Group.

OBJECTIVE: To investigate whether antifibrinolytics in combination with treatment to prevent cerebral ischemia improve outcome in patients with subarachnoid hemorrhage (SAH) in whom occlusion of the aneurysm is delayed.
BACKGROUND: Antifibrinolytic treatment reduces rebleeding, but outcome does not improve because of a concurrent increase in the occurrence of cerebral ischemia. Because treatment of ischemia has improved, antifibrinolytics might now have a beneficial effect.
METHODS: A prospective, double-blind, placebo-controlled multicenter clinical trial was performed. Randomized were 462 patients (229 received tranexamic acid, 233 placebo) admitted within 96 hours after onset of SAH, in whom treatment of the aneurysm was delayed beyond 48 hours after SAH. All patients were treated with calcium antagonists and hypervolemia. At 3 months, outcome was assessed with the Glasgow Outcome Scale. The occurrence of cerebral ischemia and other complications were recorded, and the effects of treatment were related to the clinical condition on admission.
RESULTS: Antifibrinolytic treatment had no beneficial effect on outcome (relative risk [RR], 1.10; 95% confidence limits [CL], 0.91-1.34). Antifibrinolytics significantly reduced the occurrence of rebleeding (RR, 0.58; 95% CL, 0.42-0.80); the occurrence of ischemic and other complications was the same in the two groups.
CONCLUSION: Antifibrinolytic treatment combined with treatment to prevent cerebral ischemia does not improve outcome.

RCT Entities:   Population Interventions Outcomes