Chronic Subdural HematomasBURR-MMANCT07549893
Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BURR-MMA)
A study testing CT-Guided Intra-Operative Middle Meningeal Artery Interruption in people with Chronic Subdural Hematomas, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematomas
- What is being tested?
- CT-Guided Intra-Operative Middle Meningeal Artery Interruption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
National Hospital for Neurology and Neurosurgery
London
Jigishaa Moudgil-Joshi, BMedSci MBChB MRCS, +4420 3456 7890, burrmmatrial@gmail.com
About this study
Official title: BURR-MMA: A Prospective Pilot Feasibility Study of Intra-operative Middle Meningeal Artery Coagulation During Burr-Hole Surgery for Chronic Subdural Haematoma
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.
Read the detailed description
Recurrence after burr-hole drainage of chronic subdural haematoma is driven largely by a vascularised outer membrane supplied by distal convexity branches of the middle meningeal artery. Endovascular MMA embolisation can reduce recurrence but requires a separate interventional radiology procedure and is not uniformly available across NHS centres.
BURR-MMA evaluates an alternative, in-workflow approach: limited bipolar coagulation of distal convexity MMA branches performed through the planned burr-hole during standard evacuation. Pre-operative non-contrast CT is used to map the MMA bony groove, and routine CE-marked neuronavigation is used to standardise targeting. No additional burr-holes, implants, drugs, or research-specific imaging are introduced.
This is an IDEAL Stage 2a, single-centre, single-arm feasibility study enrolling 20-30 adults undergoing burr-hole surgery for cSDH. The primary focus is technical deliverability, safety, procedural fidelity, and characterisation of iterative technique refinement. Exploratory clinical outcomes are collected to Day 90 to inform endpoint selection and sample-size calculations for a future IDEAL Stage 2b multicentre cohort study. All CT imaging is performed as part of routine clinical care; participants receive no additional ionising radiation because of study participation. The study is not powered to assess clinical effectiveness.
- Conditions
- Chronic Subdural Hematomas
- Being tested
- CT-Guided Intra-Operative Middle Meningeal Artery Interruption
- Keywords
- chronic subdural haematoma, middle meningeal artery, burrholes
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Guided Intra-Operative Middle Meningeal Artery InterruptionProcedure or surgery
Also called MMA coagulation during burr-hole surgery, Intra-operative MMA interruption
This intervention is a surgical adjunct performed during standard burr-hole evacuation of chronic subdural haematoma. Using pre-operative non-contrast CT and intra-operative neuronavigation, the surgeon identifies distal convexity branches of the middle meningeal artery (MMA) supplying the haematoma membrane. Where safely accessible, limited bipolar coagulation is applied to interrupt these branches through the planned burr-hole. Burr-hole position may be slightly adjusted within the haematoma footprint to facilitate safe targeting. If branches cannot be confidently identified or safely accessed, the adjunct is omitted and standard surgery is completed. No additional imaging or devices are introduced beyond routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Burr-Hole Evacuation With CT-Guided Intra-Operative MMA Interruption | Experimental | Participants in this single-arm feasibility study will undergo standard burr-hole evacuation of chronic subdural haematoma with subdural drain placement, in accordance with routine clinical practice. In addition, a CT- and neuronavigation-guided intra-operative adjunct will be attempted to identify and interrupt distal convexity branches of the middle meningeal artery (MMA) supplying the haematoma membrane, where this is considered safe and technically feasible by the operating surgeon.
The adjunct involves minor adjustment of burr-hole position within the haematoma footprint and limited bipolar coagulation of target MMA branches. If safe identification or access is not possible, the adjunct will be omitted and standard surgery completed.
All imaging and peri-operative care are part of standard clinical practice. The study is designed to assess feasibility, safety, procedural fidelity and workflow integration rather than clinical effectiveness. Receives: Procedure: CT-Guided Intra-Operative Middle Meningeal Artery Interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of the MMA Adjunct
Proportion of procedures in which one or more intended distal convexity MMA branches are successfully identified and coagulated by the operating surgeon, confirmed intra-operatively and by post-operative non-contrast CT showing burr-hole placement over the expected MMA bony groove. Reported as a percentage (0-100%); higher values indicate greater technical deliverability.
Measured: Intra-operative (during index procedure) and on first post-operative non-contrast CT, up to 72 hours post-operatively.
Incidence of Technique-Related Adverse Events
Number of participants experiencing at least one adverse event judged by the investigator to be related to the MMA adjunct (e.g., thermal injury, additional bleeding, equipment-related events). Reported as a count and percentage of enrolled participants.
Measured: Intra-operative through 90 days post-operatively.
Incidence of Serious Adverse Events
Number of participants experiencing at least one serious adverse event (as defined by ICH-GCP), regardless of causality. Reported as a count and percentage of enrolled participants
Measured: From index procedure through 90 days post-operatively.
Completeness of Day-90 Outcome Data Capture
Proportion of enrolled participants with complete primary outcome data available at the Day-90 follow-up, against a pre-specified feasibility target of ≥95%. Reported as a percentage.
Measured: At 90 days post-operatively.
Secondary outcomes (11)
Incidence of cSDH Recurrence Requiring Re-Intervention
Proportion of participants with radiological recurrence (increase in subdural collection size) accompanied by clinical deterioration requiring re-drainage, repeat burr-hole surgery, or rescue MMA embolisation, as determined by the treating neurosurgeon. Reported as a percentage.
Measured: Up to 90 days post-operatively
Length of Hospital Stay
Total duration of the index hospital admission, from date of surgery to date of discharge, measured in days.
Measured: During index admission (up to discharge, assessed up to 90 days post-operatively).
Incidence of Peri-Operative Complications
Number of participants experiencing one or more peri-operative surgical or medical complications (e.g., wound infection, seizure, pneumonia, venous thromboembolism, acute subdural haematoma). Reported as a count and percentage.
Measured: Intra-operative through 30 and 90 days post-operatively.
Incidence of Unplanned Hospital Readmission
Proportion of participants with at least one unplanned readmission to any hospital following discharge from the index admission. Reported as a percentage.
Measured: From discharge through 90 days post-operatively.
Functional Outcome Measured by the Modified Rankin Scale (mRS)
Functional status measured using the Modified Rankin Scale (mRS), a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcome.
Measured: At 90 days post-operatively.
Health-Related Quality of Life Measured by the EQ-5D-5L Utility Index
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument, reported as a single utility index value derived using the UK value set. Scores range from less than 0 (worse than dead) to 1 (full health); higher scores indicate better health-related quality of life.
Measured: At 90 days post-operatively.
Added Operative Time Attributable to the MMA Adjunct
Additional intra-operative time required to perform the MMA coagulation adjunct, measured from adjunct start to adjunct stop, in minutes.
Measured: Intra-operative (during index procedure).
Procedural Fidelity to the Pre-Specified Surgical SOP
Proportion of procedures in which all pre-specified SOP steps (navigation registration within tolerance, targeting of distal convexity branches only, adherence to avoidance zones, documentation completeness) are fully executed without protocol-defined deviation. Reported as a percentage.
Measured: Intra-operative (during index procedure).
Learning Effect on Added Operative Time Across Sequential Cases
Change in added operative time for the MMA adjunct across sequential cases, analysed descriptively using cumulative sum (CUSUM) methodology to identify the case number at which added operative time stabilises. Reported in minutes per case.
Measured: Through study completion (up to 12 months).
Concordance Between Pre-Operative CT MMA Groove and Intra-Operative Findings
Proportion of cases in which the distal convexity MMA branch location identified on pre-operative thin-slice non-contrast CT (via the MMA bony groove) is confirmed by intra-operative visualisation through the planned burr-hole. Reported as a percentage.
Measured: Intra-operative (during index procedure), compared against pre-operative CT performed within 7 days prior to surgery.
Feasibility of Prospective Healthcare Resource-Use Data Collection
Proportion of enrolled participants with complete prospective records of pre-defined healthcare resource-use items (length of stay, critical care days, re-operations, readmissions, rescue MMA embolisation, discharge destination) captured via the study eCRF. Reported as a percentage against a pre-specified target of ≥90%.
Measured: Through 90 days post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549893
- Sponsor's protocol ID
- 204843
- Acronym
- BURR-MMA
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in publications will be made available. This will include demographic data, clinical characteristics, imaging-derived variables, intra-operative procedural data, and outcome measures (including feasibility metrics, adverse events, and 90-day outcomes). All data will be pseudonymised, with no directly identifiable information shared.