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van CCT (UK)

van CCT (UK)

Magnesium in Aneurysmal Subarachnoid Hemorrhage.

- candidate number0
- NTR NumberNTR50
- Date ISRCTN created5-aug-2005
- date ISRCTN requested28-jul-2005
- Date Registered NTR6-jul-2005
- Secondary IDsN/A 
- Public TitleMagnesium in Aneurysmal Subarachnoid Hemorrhage.
- Scientific TitleMagnesium in Aneurysmal Subarachnoid Hemorrhage (MASH II), a phase III clinical trial.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAneurysmal subarachnoid hemorrhage, Aneurysm
- Inclusion criteriaAneurysmal subarachnoid hemorrhage.
- Exclusion criteria1. Renal failure (creatinin > 150),
2. age < 18 jaar,
3. weight < 50 kg,
4. no informed consent,
5. death is imminent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2011
- Target number of participants1200
- InterventionsMagnesium sulfate 64 mmol/d (or placebo) is started intravenously as soon as possible after informed consent and continued until 20 days after the hemorrhage.
- Primary outcomePoor outcome (dependence or death) 3 months after the subarachnoid hemorrhage (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 > 3.
- Secondary outcomeNo symptoms 3 months after the subarachnoid hemorrhage (Rankin 0 versus Rankin 1-5 or death). Global change in Rankin score.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Walter M. Bergh, van den
- CONTACT for SCIENTIFIC QUERIES Walter M. Bergh, van den
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThe MASH study is a prospective randomized, placebo-controlled, international multicenter trial to determine whether magnesium reduces the frequency of poor outcome (death or dependence) in patients admitted within 4 days after aneurysmal subarachnoid hemorrhage.
- Main changes (audit trail)
- RECORD19-jul-2005 - 20-dec-2006

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