Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124150
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2005-07-26
Brief Title:
Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage IMASH
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Phase 3 Study Multi-center Randomized Controlled Clinical Trial of Intravenous Magnesium Sulfate to Improve Outcome After Aneurysmal Subarachnoid Haemorrhage
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mmolday 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 20-25 mmolL 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
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 mmolday 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 20-25 mmolL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None