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Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, May 2008
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00124150
  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 III

Drug Information available for: Magnesium Magnesium sulfate
U.S. FDA Resources
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

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 ]

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.
Drug: Intravenous magnesium sulfate infusion
80mg per day
S: No Intervention
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

Contacts
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

Locations
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            
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

IMASH trial homepage  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
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

Keywords provided by Chinese University of Hong Kong:
subarachnoid hemorrhage
magnesium sulfate

Study placed in the following topic categories:
Calcium, Dietary
Magnesium Sulfate
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009