Chronic Subdural Hematomas
Conditions
Keywords
chronic subdural haematoma, middle meningeal artery, burrholes
Brief 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.
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.
Interventions
PROCEDURECT-Guided Intra-Operative Middle Meningeal Artery 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.
Sponsors
University College, London
University College London Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of the MMA Adjunct | Intra-operative (during index procedure) and on first post-operative non-contrast CT, up to 72 hours post-operatively. | 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 | Intra-operative through 90 days post-operatively. | 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 | From index procedure through 90 days post-operatively. | 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 | At 90 days post-operatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cSDH Recurrence Requiring Re-Intervention | Up to 90 days post-operatively | 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 | During index admission (up to discharge, assessed up to 90 days post-operatively). | Total duration of the index hospital admission, from date of surgery to date of discharge, measured in days. |
| Incidence of Peri-Operative Complications | Intra-operative through 30 and 90 days post-operatively. | 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 | From discharge through 90 days post-operatively. | Proportion of participants with at least one unplanned readmission to any hospital following discharge from the index admission. Reported as a percentage. |
| Functional Outcome Measured by the Modified Rankin Scale (mRS) | At 90 days post-operatively. | 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. |
| Health-Related Quality of Life Measured by the EQ-5D-5L Utility Index | At 90 days post-operatively. | 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. |
| Added Operative Time Attributable to the MMA Adjunct | Intra-operative (during index procedure). | Additional intra-operative time required to perform the MMA coagulation adjunct, measured from adjunct start to adjunct stop, in minutes. |
| Procedural Fidelity to the Pre-Specified Surgical SOP | Intra-operative (during index procedure). | 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. |
| Learning Effect on Added Operative Time Across Sequential Cases | Through study completion (up to 12 months). | 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. |
| Concordance Between Pre-Operative CT MMA Groove and Intra-Operative Findings | Intra-operative (during index procedure), compared against pre-operative CT performed within 7 days prior to surgery. | 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. |
| Feasibility of Prospective Healthcare Resource-Use Data Collection | Through 90 days post-operatively. | 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%. |
Countries
United Kingdom
Contacts
CONTACTJigishaa Moudgil-Joshi, MRCS, MBChB
Outcome results
None listed