Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014