Magnesium in aneurysmal subarachnoid hemorrhage (MASH II) phase III clinical trial MASH-II study group.
BACKGROUND
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%.


OBJECTIVE
To determine whether magnesium improves clinical outcome in patients with aneurysmal SAH.


METHODS
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.


RESULTS
Primary outcome will be poor clinical outcome as measured by the modified Rankin scale at 3 months.
Dorhout Mees
Sanne M
SM
University Medical Center Utrecht, Room G03.228, PO box 85500, 3508 GA, Utrecht, the Netherlands. s.m.dorhoutmees@umcutrecht.nl
D017542:Aneurysm, Ruptured / Q000150:complications; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D006801:Humans; D002532:Intracranial Aneurysm / Q000150:complications / Q000188:drug therapy*; D008278:Magnesium Sulfate / Q000627:therapeutic use*; D013345:Subarachnoid Hemorrhage / Q000188:drug therapy* / Q000209:etiology
D000889:Anti-Arrhythmia Agents; D008278:Magnesium Sulfate