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.
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.
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.
Single group
CT-Guided Intra-Operative Middle Meningeal Artery Interruption
Procedure/SurgeryThis 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.
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.
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.
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
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.
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.
Length of Hospital Stay
Total duration of the index hospital admission, from date of surgery to date of discharge, measured in days.
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.
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.
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University College, London
Lead sponsor
University College London Hospitals
Collaborator
