Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000058673
Ethics application status
Approved
Date submitted
22/07/2005
Date registered
1/08/2005
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Prospectively 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
Secondary ID [1] 296532 0
nil
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
1/01/2010
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
190
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 12366 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 24628 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 201 0
Self funded/Unfunded
Name [1] 201 0
Country [1] 201 0
Primary sponsor type
Commercial sector/Industry
Name
Pharmalab
Address
332 Burns Bay rd Lane Cove
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
Ethics committee name [4] 301864 0
Northern Sydney Health
Ethics committee address [4] 301864 0
RNSH St Leonards
Ethics committee country [4] 301864 0
Australia
Date submitted for ethics approval [4] 301864 0
01/01/2004
Approval date [4] 301864 0
01/01/2004
Ethics approval number [4] 301864 0

Summary
Brief summary
Patients had a reduced incidence of vasospasm but the resul was not significant.
There was no difference between groupw
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35863 0
Dr Celia Bradford
Address 35863 0
c/o Royal North Shore ICU
Level 6 RNSH
St Leonards 2065
Country 35863 0
Australia
Phone 35863 0
+61 0414777988
Fax 35863 0
Email 35863 0
[email protected]
Contact person for public queries
Name 9240 0
Dr 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
[email protected]
Contact person for scientific queries
Name 168 0
Mrs 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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Critical Care and Resuscitation: Vol 15, Issue 2 (... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomised controlled trial of induced hypermagnesaemia following aneurysmal subarachnoid haemorrhage2013https://doi.org/10.1016/s1441-2772(23)01778-7
N.B. These documents automatically identified may not have been verified by the study sponsor.