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Magnesium in aneurysmal subarachnoid hemorrhage (MASH II) phase III clinical trial MASH-II study group
1University Medical Center Utrecht, Room G03.228, PO box 85500, 3508 GA, Utrecht, the Netherlands. s.m.dorhoutmees@umcutrecht.nl
Rationale:
Delayed cerebral ischemia (DCI) is an important cause of poor outcome after aneurysmal subarachnoid hemorrhage (SAH). Magnesium is a neuroprotective agent that acts as an NMDA-receptor antagonist and a calcium channel blocker. In a phase II randomized clinical trial of 283 patients, magnesium treatment reduced the risk of DCI by 34% and of poor outcome by 23%.
Aims:
To determine whether magnesium improves clinical outcome in patients with aneurysmal SAH.
Design:
The MASH-II study is a phase III randomized, clinical international multicenter trial. Magnesium sulfate 64 mmol/day (equals 16 g/day) or placebo is started intravenously within 4 days after the SAH and is continued until 20 days after the hemorrhage. The primary outcome measure is poor outcome, defined as death or dependence (Rankin score >3) after 3 months. We aim to include 1200 patients in 5 years.
Study Outcomes:
Primary outcome will be poor clinical outcome as measured by the modified Rankin scale at 3 months.
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