Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
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|ClinicalTrials.gov Identifier: NCT00124150|
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : December 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: Intravenous magnesium sulfate infusion||Phase 3|
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.
After obtaining randomisation code:
- 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,
- Study drug to be infused for 14 days from the day of hemorrhage (regarded as day 0).
- 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.
- 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
6 years with a refined sample size of 340 after analysis of pilot study data; with planned interim analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Phase 3 Study (Multi-center, Randomized Controlled Clinical Trial) of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||June 2009|
Intravenous magnesium sulfate infusion for 14 days.
Drug: Intravenous magnesium sulfate infusion
80mg per day
No Intervention: S
Saline infusion without additional magnesium sulfate.
- Extended Glasgow Outcome Scale [ Time Frame: At six months ]
- Incidence of clinical vasospasm [ Time Frame: Within first 14 days ]
- Barthel Index [ Time Frame: At six months ]
- Modified Rankin Score [ Time Frame: At six months ]
- Modified National Institute of Health Stroke Score [ Time Frame: At six months ]
- Other major complications requiring intensive care unit admission [ Time Frame: During first 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124150
|Department of Surgery, The Chinese University of Hong Kong|
|Hong Kong, China, 852|
|Principal Investigator:||Wai S Poon, MB ChB FRCS||Department of Surgery, The Chinese University of Hong Kong|