CARE pilot trial
Research type
Research Study
Full title
Cavernomas A Randomised Effectiveness (CARE) pilot trial, to address the effectiveness of medical management versus medical and surgical management (with neurosurgery or stereotactic radiosurgery) in people with symptomatic brain cavernoma
IRAS ID
289197
Contact name
Rustam Al-Shahi Salman
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
A cavernoma is a cluster of blood vessels that form blood-filled ‘caverns’ that look like a raspberry. Brain cavernomas can cause strokes or epileptic seizures. In the UK, most people with cavernomas have medical management (which may involve scans, drugs, or rehabilitation) to manage these symptoms. About one fifth also have ‘surgical management’ with either brain surgery to remove a cavernoma or stereotactic radiosurgery to stabilise it with radiation.
The pros and cons of medical management versus medical and surgical management are finely balanced. Finding out which is best was identified through work involving the charity Cavernoma Alliance UK as a top priority for cavernoma research. We first need to find out whether enough patients can be found for a randomised trial comparing ‘medical management' with ‘medical and surgical management’ of symptomatic cavernomas. We need to know this because cavernomas are rare and we do not know whether patients and doctors will take part. This will be the first randomised trial of its kind for brain cavernoma.
We will recruit patients of all ages with brain cavernoma who meet the eligibility criteria, where there is uncertainty about the best treatment option. Participants will be allocated at random to either medical management or medical and surgical treatment (neurosurgery or stereotactic radiosurgery). If patients do not have a preference for surgical treatment, type, they may be allocated randomly to neurosurgery or stereotactic radiosurgery. We aim to recruit ~60 participants.
An integrated qualitative research component (QuinteT), including analysis of screening log data and qualitative research (including interviews with patients and research staff), is included to understand recruitment processes and barriers as well as actions to address barriers.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0046
Date of REC Opinion
31 Mar 2021
REC opinion
Further Information Favourable Opinion