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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

July 26, 2005
December 21, 2009
June 2002
December 2008   (final data collection date for primary outcome measure)
Extended Glasgow Outcome Scale [ Time Frame: At six months ] [ Designated as safety issue: No ]
Extended Glasgow Outcome Scale at six months
Complete list of historical versions of study NCT00124150 on ClinicalTrials.gov Archive Site
  • 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 ]
Incidence of clinical vasospasm, Barthel Index; modified Rankin score, modified National Institute of Health Stroke Score, MCA velocities, other major complications
Not Provided
Not Provided
 
Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)
Phase 3 Study (Multi-center, Randomized Controlled Clinical Trial) of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage

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?"

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Subarachnoid Hemorrhage
Drug: Intravenous magnesium sulfate infusion
80mg per day
  • Experimental: M
    Intravenous magnesium sulfate infusion for 14 days.
    Intervention: Drug: Intravenous magnesium sulfate infusion
  • No Intervention: S
    Saline infusion without additional magnesium sulfate.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
June 2009
December 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00124150
IMASH trial
Yes
George KC WONG, Division of Neurosurgery, The Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Wai S Poon, MB ChB FRCS Department of Surgery, The Chinese University of Hong Kong
Chinese University of Hong Kong
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP