Magnesium in Aneurysmal Subarachnoid Haemorrhage
| ISRCTN | ISRCTN68742385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68742385 |
| EudraCT/CTIS number | 2006-003523-36 |
| Secondary identifying numbers | NTR50 |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 01/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Walter M. van den Bergh
Scientific
Scientific
PO Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2508350 |
|---|---|
| w.m.vandenbergh@neuro.azu.nl |
Study information
| Study design | Multi-centre randomised double-blind placebo-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Magnesium in Aneurysmal Subarachnoid Haemorrhage (MASH): a phase III clinical trial |
| Study acronym | MASH |
| Study objectives | 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. |
| Ethics approval(s) | Ethics approval received from local ethics committee |
| Health condition(s) or problem(s) studied | Aneurysmal subarachnoid haemorrhage |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | 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. |
| Secondary outcome measures | 1. No symptoms 3 months after the subarachnoid haemorrhage (Rankin 0 versus Rankin 1 - 5 or death) 2. Global change in Rankin score |
| Overall study start date | 01/01/2006 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 |
| Key inclusion criteria | Aneurysmal subarachnoid haemorrhage |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
University/education
University Medical Centre Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | meta-analysis | 01/09/2011 | Yes | No | |
| Results article | results | 07/07/2012 | Yes | No | |
| Results article | substudy results | 01/10/2015 | Yes | No |
Editorial Notes
01/08/2016: Publication reference added.
