Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
|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|
|Primary Completion Date :||December 2008|
|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 ]
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|