Condition category
Circulatory System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
01/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Walter M. van den Bergh

ORCID ID

Contact details

PO Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2508350
w.m.vandenbergh@neuro.azu.nl

Additional identifiers

EudraCT number

2006-003523-36

ClinicalTrials.gov number

Protocol/serial number

NTR50

Study information

Scientific title

Magnesium in Aneurysmal Subarachnoid Haemorrhage (MASH): a phase III clinical trial

Acronym

MASH

Study hypothesis

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

Ethics approval received from local ethics committee

Study design

Multi-centre randomised double-blind placebo-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Phase III

Drug names

Magnesium sulphate

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Aneurysmal subarachnoid haemorrhage

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

PO Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl

Funders

Funder type

University/education

Funder name

University Medical Centre Utrecht (UMCU) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 meta-analysis in: http://www.ncbi.nlm.nih.gov/pubmed/21489317
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22633825
2015 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/26502971

Publication citations

  1. Results

    Dorhout Mees SM, Algra A, Vandertop WP, van Kooten F, Kuijsten HA, Boiten J, van Oostenbrugge RJ, Al-Shahi Salman R, Lavados PM, Rinkel GJ, van den Bergh WM, , Magnesium for aneurysmal subarachnoid haemorrhage (MASH-2): a randomised placebo-controlled trial., Lancet, 2012, 380, 9836, 44-49, doi: 10.1016/S0140-6736(12)60724-7.

  2. Results

    Vergouwen MD, Magnesium sulfate for aneurysmal subarachnoid hemorrhage: the end of the road or more trials?, Crit Care, 2011, 15, 2, 140, doi: 10.1186/cc10055.

  3. Results

    Leijenaar JF, Dorhout Mees SM, Algra A, van den Bergh WM, Rinkel GJ; MASH-II Study Group, Effect of magnesium treatment and glucose levels on delayed cerebral ischemia in patients with subarachnoid hemorrhage: a substudy of the Magnesium in Aneurysmal Subarachnoid Haemorrhage trial (MASH-II), Int J Stroke, 2015 , 10 , Suppl A100, 108-112, doi: 10.1111/ijs.12621.

Additional files

Editorial Notes

01/08/2016: Publication reference added.