Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
This study has been completed.
Sponsor:
Chinese University of Hong Kong
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00124150
First received: July 26, 2005
Last updated: December 21, 2009
Last verified: July 2009
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Phase 3 Study (Multi-center, Randomized Controlled Clinical Trial) of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Extended Glasgow Outcome Scale [ Time Frame: At six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of clinical vasospasm [ Time Frame: Within first 14 days ] [ Designated as safety issue: No ]
- Barthel Index [ Time Frame: At six months ] [ Designated as safety issue: No ]
- Modified Rankin Score [ Time Frame: At six months ] [ Designated as safety issue: No ]
- Modified National Institute of Health Stroke Score [ Time Frame: At six months ] [ Designated as safety issue: No ]
- Other major complications requiring intensive care unit admission [ Time Frame: During first 14 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 327 |
| Study Start Date: | June 2002 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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:
- 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:
6 years with a refined sample size of 340 after analysis of pilot study data; with planned interim analysis.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124150
Locations
| China | |
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | George KC WONG, Division of Neurosurgery, The Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00124150 History of Changes |
| Other Study ID Numbers: | IMASH trial |
| Study First Received: | July 26, 2005 |
| Last Updated: | December 21, 2009 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
subarachnoid hemorrhage magnesium sulfate |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013