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	Intervention	Phase
Subarachnoid Hemorrhage	Drug: Intravenous magnesium sulfate	Phase III

Further Study Details: 

Primary Outcomes: Extended Glasgow Outcome Scale at six months
Secondary Outcomes: Incidence of clinical vasospasm, Barthel Index; modified Rankin score, modified National Institute of Health Stroke Score, MCA velocities, other major complications
Expected Total Enrollment:  500

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:

• 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

Study duration: 5 years with interim analyses at n = 250 and 500 patients

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ASAH (as indicated by CT scan or lumbar puncture and an intracranial aneurysm confirmed by computer tomographic or conventional angiography)
• Within 48 hrs of ictus (hemorrhage event)

Exclusion Criteria:

• Pregnancy
• Major renal, hepatic or pulmonary disease
• Major cardiac disease or recent myocardial infarct (< 6 months)
• Age less than 18 years
• 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00124150

George Wong KC Wong, MB ChB FRCS(SN)      +852 2632 2624    georgewong@surgery.cuhk.edu.hk
Wayne WS Poon, MB ChB FRCS      +852 2632 2638    wpoon@surgery.cuhk.edu.hk

China
      Department of Surgery, Chinese University of Hong Kong, Hong Kong,  852,  China; Recruiting

Study chairs or principal investigators

Wayne WS Poon, MB ChB FRCS,  Principal Investigator,  Department of Surgery, Chinese University of Hong Kong   

Study ID Numbers:  IMASH trial; CUHK 4183/02M
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124150
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-02