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Trial registered on ANZCTR


Trial ID
ACTRN12605000058673
Ethics application status
Approved
Date submitted
22/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnesium in Aneurysmal Subarachnoid Haemorrhage
Scientific title
A multi-centre, single blinded, randomised controlled trial of two target ranges for serum magnesium in patients with Subarachnoid Haemorrhage to reduce vasospasm
Universal Trial Number (UTN)
Trial acronym
MASH Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subarachnoid Haemorrhage
129 0
130 0
Condition category
Condition code
Blood 148 148 0 0
Other neurological disorders
Blood 149 149 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnesium sulfate (20ml/hr). The concentration of magnesium will be titrated to the serum magnesium level in order to achieve a serum level of 1.6-2.5mmol/L, in the treatment group.
Intervention code [1] 51 0
None
Comparator / control treatment
Placebo (normal saline 20ml/hr). The concentration will be titrated 0.65 - 1.05 mmol/L in the placebo arm.
Control group
Placebo

Outcomes
Primary outcome [1] 185 0
The incidence and severity of vasospasm as detected by cerebral angiography
Timepoint [1] 185 0
Secondary outcome [1] 413 0
1/Mortality
Timepoint [1] 413 0
Secondary outcome [2] 414 0
2/Glasgow Outcome Score
Timepoint [2] 414 0
At 90 days.
Secondary outcome [3] 415 0
3/ Modified Rankin
Timepoint [3] 415 0
At 90 days.

Eligibility
Key inclusion criteria
<72 hours since haemorrhage
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1/Traumatic SAH. 2/Creatinine >0.2mmol/l. 3/Myasthenia Gravis. 4/Death imminent. 5/Vasospasm present on hospital admission.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss- stratification for grade of subarachnoid haemorrhage. Blocking.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 201 0
Self funded/Unfunded
Name [1] 201 0
Address [1] 201 0
Country [1] 201 0
Primary sponsor type
Commercial sector/Industry
Name
Pharmalab
Address
Country
Australia
Secondary sponsor category [1] 150 0
None
Name [1] 150 0
Not applicable
Address [1] 150 0
Country [1] 150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 962 0
Royal North Shore Hospital
Ethics committee address [1] 962 0
Ethics committee country [1] 962 0
Australia
Date submitted for ethics approval [1] 962 0
Approval date [1] 962 0
Ethics approval number [1] 962 0
Ethics committee name [2] 963 0
Dalcross Private Hospital
Ethics committee address [2] 963 0
Ethics committee country [2] 963 0
Australia
Date submitted for ethics approval [2] 963 0
Approval date [2] 963 0
Ethics approval number [2] 963 0
Ethics committee name [3] 964 0
Royal Hobart Hospital
Ethics committee address [3] 964 0
Ethics committee country [3] 964 0
Australia
Date submitted for ethics approval [3] 964 0
Approval date [3] 964 0
Ethics approval number [3] 964 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35863 0
Address 35863 0
Country 35863 0
Phone 35863 0
Fax 35863 0
Email 35863 0
Contact person for public queries
Name 9240 0
Celia Bradford
Address 9240 0
c/o Intensive Care
Royal North Shore Hospital
Level 6 Main Block
St Leonards NSW 2065
Country 9240 0
Australia
Phone 9240 0
+61 2 99267851
Fax 9240 0
+61 2 94398418
Email 9240 0
celiabradford@telstra.com
Contact person for scientific queries
Name 168 0
Anne O'Connor
Address 168 0
c/o Intensive Care
Royal North Shore Hospital
Level 6 Main Block
St Leonards NSW 2065
Country 168 0
Australia
Phone 168 0
+61 2 99267851
Fax 168 0
+61 2 94398418
Email 168 0
aoconnor@nsccahs.health.nsw.gov.au