Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)

NCT00124150 | Completed Phase 3 DMC

• 1 other identifier: IMASH trial
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

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?"

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhage; magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• Extended Glasgow Outcome Scale

  At six months

Secondary Outcomes (5)

• Incidence of clinical vasospasm

  Within first 14 days

• Barthel Index

  At six months

• Modified Rankin Score

  At six months

• Modified National Institute of Health Stroke Score

  At six months

• Other major complications requiring intensive care unit admission

  During first 14 days

Study Arms (2)

M

EXPERIMENTAL

Intravenous magnesium sulfate infusion for 14 days.

Drug: Intravenous magnesium sulfate infusion

S

NO INTERVENTION

Saline infusion without additional magnesium sulfate.

Interventions

Intravenous magnesium sulfate infusion DRUG

80mg per day

M

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, The Chinese University of Hong Kong

Hong Kong, 852, China

Location

Related Publications (10)

• Boet R, Mee E. Magnesium sulfate in the management of patients with Fisher Grade 3 subarachnoid hemorrhage: a pilot study. Neurosurgery. 2000 Sep;47(3):602-6; discussion 606-7. doi: 10.1097/00006123-200009000-00014.

  PMID: 10981747 BACKGROUND

• Boet R, Poon WS, Chan MT. Re: Magnesium: a useful adjunct in the prevention of cerebral vasospasm following aneurysmal subarachnoid haemorrhage. J Clin Neurosci. 2003 May;10(3):394. doi: 10.1016/s0967-5868(03)00006-7. No abstract available.

  PMID: 12763359 BACKGROUND

• Wong GK, Poon WS, Chan MT, Boet R, Gin T, Lam CW. The effect of intravenous magnesium sulfate infusion on serum levels of sodium and potassium in patients with aneurysmal subarachnoid hemorrhage. Magnes Res. 2007 Mar;20(1):37-42.

  PMID: 17536487 BACKGROUND

• Boet R, Chan MT, Poon WS, Wong GK, Wong HT, Gin T. Intravenous magnesium sulfate to improve outcome after aneurysmal subarachnoid hemorrhage: interim report from a pilot study. Acta Neurochir Suppl. 2005;95:263-4. doi: 10.1007/3-211-32318-x_53.

  PMID: 16463861 RESULT

• Wong GK, Chan MT, Boet R, Poon WS, Gin T. Intravenous magnesium sulfate after aneurysmal subarachnoid hemorrhage: a prospective randomized pilot study. J Neurosurg Anesthesiol. 2006 Apr;18(2):142-8. doi: 10.1097/00008506-200604000-00009.

  PMID: 16628069 RESULT

• Wong GK, Chan MT, Poon WS, Boet R, Gin T. Magnesium therapy within 48 hours of an aneurysmal subarachnoid hemorrhage: neuro-panacea. Neurol Res. 2006 Jun;28(4):431-5. doi: 10.1179/016164106X115035.

  PMID: 16759446 RESULT

• Wong GK, Chan MT, Boet R, Poon WS. Correspondence to 'dose evaluation for long-term magnesium treatment in aneurysmal subarachnoid haemorrhage'. J Clin Pharm Ther. 2006 Aug;31(4):407. doi: 10.1111/j.1365-2710.2006.00728.x. No abstract available.

  PMID: 16882114 RESULT

• Wong GK, Poon WS. Clinical, transcranial Doppler ultrasound, radiological features and, prognostic significance of delayed cerebral ischemia. Acta Neurochir Suppl. 2013;115:9-11. doi: 10.1007/978-3-7091-1192-5_3.

  PMID: 22890635 DERIVED

• Wong GK, Poon WS, Boet R, Chan MT, Gin T, Ng SC, Zee BC. Health-related quality of life after aneurysmal subarachnoid hemorrhage: profile and clinical factors. Neurosurgery. 2011 Jun;68(6):1556-61; discussion 1561. doi: 10.1227/NEU.0b013e31820cd40d.

  PMID: 21311383 DERIVED

• Wong GK, Poon WS, Chan MT, Boet R, Gin T, Ng SC, Zee BC; IMASH Investigators. Intravenous magnesium sulphate for aneurysmal subarachnoid hemorrhage (IMASH): a randomized, double-blinded, placebo-controlled, multicenter phase III trial. Stroke. 2010 May;41(5):921-6. doi: 10.1161/STROKEAHA.109.571125. Epub 2010 Apr 8.

  PMID: 20378868 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wai S Poon, MB ChB FRCS

  Department of Surgery, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: July 27, 2005
• Study Start: June 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-07

Locations

CN (1)