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Randomized Controlled Trial
Randomized controlled trial of acetylsalicylic acid in aneurysmal subarachnoid hemorrhage: the MASH Study.
- Walter M van den Bergh, MASH Study Group, A Algra, S M Dorhout Mees, F van Kooten, C M F Dirven, J van Gijn, M Vermeulen, and G J E Rinkel.
- MASH Study, The Netherlands. w.m.vandenbergh@umcutrecht.nl
- Stroke. 2006 Sep 1; 37 (9): 2326-30.
Background And PurposeA previous systematic review of randomized trials suggested a positive effect of antiplatelet therapy in patients with aneurysmal subarachnoid hemorrhage (SAH). We performed a randomized controlled trial to assess whether acetylsalicylic acid (ASA) reduces the risk of delayed ischemic neurological deficit (DIND) in patients with SAH.MethodsCriteria for inclusion were aneurysm treatment within 4 days after SAH. Trial medication (14 daily suppositories with 100 mg ASA or placebo) was started within 12 hours after aneurysm treatment. Analysis for the primary outcome event DIND was made according to the "on-treatment" principle and for the secondary outcome measures "poor outcome" and "nonexcellent outcome" according to the "intention-to-treat" principle.ResultsInclusion was stopped after the second interim analysis, when 161 of the planned 200 patients were included, because by then the chances of a positive effect were negligible. At the final analysis, ASA did not reduce the risk of DIND (hazard ratio, 1.83; 95% CI, 0.85 to 3.9). The relative risk reduction for poor outcome was 21% (relative risk, 0.79; 95% CI, 0.38 to 1.6).ConclusionsASA given after aneurysm treatment does not appreciably reduce the occurrence of DIND.
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