Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BUR… (NCT07549893) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BURR-MMA)
30 participantsStarted 2026-08-01
Plain-language summary
Chronic subdural haematoma (cSDH) is a common condition in older adults, usually treated by burr-hole surgery to drain the collection. Even with good surgery, around 1 in 10 patients develop a recurrence and need a second operation. Research shows that the outer lining of the haematoma is fed by small branches of the middle meningeal artery (MMA), and interrupting these branches may lower the risk of recurrence.
This study looks at whether surgeons can safely and reliably coagulate these small MMA branches at the same time as standard burr-hole drainage, using the routine pre-operative CT scan and surgical navigation already used in everyday practice. Adults (aged 18 years and over) scheduled for burr-hole drainage of a chronic or subacute subdural haematoma will be invited to take part. The procedure, recovery, drain management, and 90-day follow-up will otherwise follow standard NHS care.
No additional imaging is required for the study, and participants are not exposed to any extra radiation. The main purpose is feasibility and safety, not to prove effectiveness. Findings will inform the design of a future multicentre study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years.
* Chronic or subacute subdural haematoma scheduled for burr-hole evacuation.
* Treating surgeon considers the CT- and navigation-guided MMA adjunct technically feasible and safe to attempt, recognising that the adjunct may be abandoned intra-operatively according to protocol bail-out criteria.
* Written informed consent, or consultee declaration under the Mental Capacity Act (MCA), with re-consent if capacity returns.
Consented participants who meet eligibility criteria will be enrolled sequentially until the target sample size of 20-30 participants is reached. No randomisation is used in this feasibility phase.
Exclusion Criteria:
* Acute subdural haematoma requiring craniotomy or decompressive surgery.
* Prior ipsilateral MMA embolisation.
* Clear contraindication to pre-operative CT
* Inability to complete Day-90 follow-up.
* Pregnancy or breastfeeding (due to radiation exposure from CT imaging as part of standard clinical care).
If CT is non-diagnostic or cannot be performed, participants will continue with standard burr-hole evacuation without the MMA adjunct; this does not constitute a protocol deviation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Technical Success of the MMA Adjunct
Timeframe: Intra-operative (during index procedure) and on first post-operative non-contrast CT, up to 72 hours post-operatively.
2
Incidence of Technique-Related Adverse Events
Timeframe: Intra-operative through 90 days post-operatively.
3
Incidence of Serious Adverse Events
Timeframe: From index procedure through 90 days post-operatively.