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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00124150 |
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 infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study (Multi-Center, Randomized Controlled Clinical Trial) of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage |
Estimated Enrollment: | 340 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
M: Experimental
Intravenous magnesium sulfate infusion for 14 days.
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Drug: Intravenous magnesium sulfate infusion
80mg per day
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S: No Intervention
Saline infusion without additional magnesium sulfate.
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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:
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: George Wong KC Wong, FRCS(SN) | +852 2632 2624 | georgewong@surgery.cuhk.edu.hk |
Contact: Wai S Poon, FRCS(Glasgow) | +852 2632 2638 | wpoon@surgery.cuhk.edu.hk |
China | |
Department of Surgery, The Chinese University of Hong Kong | Recruiting |
Hong Kong, China, 852 | |
Contact: George KC Wong, FRCS(SN) +852 2632 2624 georgewong@surgery.cuhk.edu.hk | |
Contact: Wai S Poon, FRCS +852 2632 2638 wpoon@surgery.cuhk.edu.hk | |
Principal Investigator: Wai S Poon, MB ChB FRCS |
Principal Investigator: | Wai S Poon, MB ChB FRCS | Department of Surgery, The Chinese University of Hong Kong |
Responsible Party: | Division of Neurosurgery, The Chinese University of Hong Kong ( George KC WONG ) |
Study ID Numbers: | IMASH trial, CUHK 4183/02M |
Study First Received: | July 26, 2005 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00124150 |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
subarachnoid hemorrhage magnesium sulfate |
Calcium, Dietary Magnesium Sulfate Vascular Diseases Subarachnoid Hemorrhage Central Nervous System Diseases |
Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders |
Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Central Nervous System Depressants Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Pathologic Processes Tocolytic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |