MAnnitol for Cerebral oEdema after IntraCerebral Haemorrhage (MACE-ICH)
Research type
Research Study
Full title
MAnnitol for Cerebral oEdema after IntraCerebral Haemorrhage (MACE-ICH): a feasibility trial
IRAS ID
1004870
Contact name
KAILASH KRISHNAN
Contact email
Eudract number
2022-000283-22
ISRCTN Number
ISRCTN15383301
Research summary
Stroke from bleeding into the brain, known as intracerebral haemorrhage(ICH) affects about 15,000 adults in the UK each year and to-date there is no effective treatment. Brain swelling after ICH is common and can worsen damage resulting in disability or death. Large haemorrhages (~10-15%) cause brain swelling very quickly and the only option that is possible in some young patients is to do a major operation and make more space for the brain to expand. It is unclear whether surgery is beneficial and the operation has its own risks. So, finding treatments which prevent or stop brain swelling after ICH could reduce death or disability.
Mannitol is a widely available drug and as an injection through a vein can reduce brain swelling after severe head injury or liver damage. It is cheap and easy to give. Small studies suggest that mannitol may also reduce brain swelling after ICH, but no definite study has been performed.
We want to test if it is possible to do a small study of mannitol in ICH to find out how acceptable and manageable it is to inform a larger study. Forty-five adult patients with ICH with or at risk of brain swelling from ten UK hospitals will be recruited within 72 hours after stroke. Using a computer, participants will be allocated like the roll of a dice to one of three groups: single mannitol injection; two mannitol injections or standard medical care alone.
Participants will be monitored for side effects, urine output, undergo blood tests and clinical assessments during and after treatment. We will do a repeat brain scan 5-7 days after treatment to see whether mannitol has reduced brain swelling. At 6 months, information on survival, participant’s quality of life, mood, memory, disability and health problems in those who had Covid will be collected through telephone postal structured questionnaires. If a participant is unable to provide information, we will contact their relative/carer or GP.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0242
Date of REC Opinion
10 May 2023
REC opinion
Further Information Favourable Opinion