Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
Study Details
Study Description
Brief Summary
The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center trial to answer the question: "Does intravenous magnesium sulfate improve clinical outcome after aneurysmal subarachnoid hemorrhage?"
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Vasospasm worsen outcome in patients with aneurysmal subarachnoid hemorrhage (ASAH).
Magnesium is known to dilate cerebral arteries and to block N-methyl-D-aspartate receptors in the injured neurons.
Intravenous magnesium may prevent vasospasm after subarachnoid hemorrhage and may protect neurons against damage during established vasospasm.
The IMASH trial is a randomized, placebo-controlled, double-blinded, multi-center trial to evaluate the effect that intravenous magnesium sulfate infusion on the clinical outcome of patients with aneurysmal subarachnoid haemorrhage.
Methods:
After obtaining randomisation code:
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Start MgSO4 20 mmol over 30 minutes, followed by infusion of 80 mmol/day or equivalent volume of saline within 48 h after onset of symptom,
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Study drug to be infused for 14 days from the day of hemorrhage (regarded as day 0).
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Measure plasma magnesium concentration daily and perform transcranial Doppler to monitor blood flow velocities of both middle cerebral arteries and extracranial segment of the internal carotid arteries.
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Plasma magnesium concentration in the IV MgSO4 group should be raised to 2.0-2.5 mmol/L or twice the serum baseline level. Patients that are randomized to saline infusion will only have their magnesium levels normalized if there is a clinical indication to do so.
Outcome assessment Primary outcome: Extended Glasgow Outcome Scale at six months Secondary outcome: Incidence of clinical vasospasm, Barthel Index; modified Rankin score, modified National Institute of Health Stroke Score, MCA velocities, other major complications
Study duration:
6 years with a refined sample size of 340 after analysis of pilot study data; with planned interim analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: M Intravenous magnesium sulfate infusion for 14 days. |
Drug: Intravenous magnesium sulfate infusion
80mg per day
|
| No Intervention: S Saline infusion without additional magnesium sulfate. |
Outcome Measures
Primary Outcome Measures
- Extended Glasgow Outcome Scale [At six months]
Secondary Outcome Measures
- Incidence of clinical vasospasm [Within first 14 days]
- Barthel Index [At six months]
- Modified Rankin Score [At six months]
- Modified National Institute of Health Stroke Score [At six months]
- Other major complications requiring intensive care unit admission [During first 14 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASAH (as indicated by CT scan or lumbar puncture and an intracranial aneurysm confirmed by computer tomographic or conventional angiography)
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Within 48 hrs of ictus (hemorrhage event)
Exclusion Criteria:
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Pregnancy
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Major renal, hepatic or pulmonary disease
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Major cardiac disease or recent myocardial infarct (< 6 months)
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Age less than 18 years
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Moribund condition on admission (defined as a patient that is in such a poor clinical condition that further active neurosurgical management would not be anticipated)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, The Chinese University of Hong Kong | Hong Kong | China | 852 |
Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
- Principal Investigator: Wai S Poon, MB ChB FRCS, Department of Surgery, The Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
- Boet R, Mee E. Magnesium sulfate in the management of patients with Fisher Grade 3 subarachnoid hemorrhage: a pilot study. Neurosurgery. 2000 Sep;47(3):602-6; discussion 606-7.
- Boet R, Poon WS, Chan MT. Re: Magnesium: a useful adjunct in the prevention of cerebral vasospasm following aneurysmal subarachnoid haemorrhage. J Clin Neurosci. 2003 May;10(3):394.
- Wong GK, Poon WS, Chan MT, Boet R, Gin T, Lam CW. The effect of intravenous magnesium sulfate infusion on serum levels of sodium and potassium in patients with aneurysmal subarachnoid hemorrhage. Magnes Res. 2007 Mar;20(1):37-42.
- IMASH trial