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 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
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
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
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
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
No documents have been uploaded by study researchers.

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.