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ISRCTN
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ISRCTN68742385
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DOI
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10.1186/ISRCTN68742385
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ClinicalTrials.gov identifier
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EudraCT number
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2006-003523-36
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Public title
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Magnesium in Aneurysmal Subarachnoid Haemorrhage
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Scientific title
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Magnesium in Aneurysmal Subarachnoid Haemorrhage (MASH): a phase III clinical trial
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Acronym
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MASH
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Serial number at source
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NTR50
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Study hypothesis
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The MASH study is a prospective randomised, placebo-controlled, international multi-centre trial to determine whether magnesium reduces the frequency of poor outcome (death or dependence) in patients admitted within four days after aneurysmal subarachnoid haemorrhage.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from local ethics committee
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Study design
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Multi-centre, randomised, double-blind, placebo controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Aneurysmal subarachnoid haemorrhage
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Participants - inclusion criteria
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Aneurysmal subarachnoid haemorrhage.
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Participants - exclusion criteria
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1. Renal failure (creatinine greater than 150)
2. Age less than 18 years
3. Weight less than 50 kg
4. No informed consent
5. Death is imminent
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/01/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1200
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Interventions
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Magnesium sulphate 64 mmol/day (or placebo) is started intravenously as soon as possible after informed consent and continued until 20 days after the haemorrhage.
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Primary outcome measure(s)
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Poor outcome (dependence or death) 3 months after the subarachnoid haemorrhage (Rankin 0 - 3 versus Rankin 4 - 5, or death) as assessed with the modified Rankin scale during a telephone interview. Dependence will be defined as a Rankin score greater than 3.
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Secondary outcome measure(s)
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1. No symptoms 3 months after the subarachnoid haemorrhage (Rankin 0 versus Rankin 1 - 5 or death)
2. Global change in Rankin score
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Sources of funding
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University Medical Centre Utrecht (UMCU) (The Netherlands)
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Trial website
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Publications
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1. 2011 meta-analysis in http://www.ncbi.nlm.nih.gov/pubmed/21489317
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22633825
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Contact name
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Dr
Walter M.
van den Bergh
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Address
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P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Tel
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+31 (0)30 2508350
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Email
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w.m.vandenbergh@neuro.azu.nl
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Sponsor
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University Medical Centre Utrecht (UMCU) (The Netherlands)
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Address
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P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Sponsor website:
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http://www.umcutrecht.nl
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Date applied
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04/08/2005
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Last edited
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30/10/2012
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Date ISRCTN assigned
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04/08/2005
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