Middle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BURR-MMA)

Official title

BURR-MMA: A Prospective Pilot Feasibility Study of Intra-operative Middle Meningeal Artery Coagulation During Burr-Hole Surgery for Chronic Subdural Haematoma

Overview

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

• Procedure CT-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 f

Primary outcome measures

• Technical Success of the MMA Adjunct [Time frame: 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 [Time frame: Intra-operative through 90 days post-operatively.]
• Incidence of Serious Adverse Events [Time frame: From index procedure through 90 days post-operatively.]
• Completeness of Day-90 Outcome Data Capture [Time frame: At 90 days post-operatively.]

Secondary outcome measures (11)

• Incidence of cSDH Recurrence Requiring Re-Intervention [Time frame: Up to 90 days post-operatively]
• Length of Hospital Stay [Time frame: During index admission (up to discharge, assessed up to 90 days post-operatively).]
• Incidence of Peri-Operative Complications [Time frame: Intra-operative through 30 and 90 days post-operatively.]
• Incidence of Unplanned Hospital Readmission [Time frame: From discharge through 90 days post-operatively.]
• Functional Outcome Measured by the Modified Rankin Scale (mRS) [Time frame: At 90 days post-operatively.]
• Health-Related Quality of Life Measured by the EQ-5D-5L Utility Index [Time frame: At 90 days post-operatively.]
• Added Operative Time Attributable to the MMA Adjunct [Time frame: Intra-operative (during index procedure).]
• Procedural Fidelity to the Pre-Specified Surgical SOP [Time frame: Intra-operative (during index procedure).]
• Learning Effect on Added Operative Time Across Sequential Cases [Time frame: Through study completion (up to 12 months).]
• Concordance Between Pre-Operative CT MMA Groove and Intra-Operative Findings [Time frame: 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 [Time frame: Through 90 days post-operatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• National Hospital for Neurology and Neurosurgery — London

Identifiers

NCT: NCT07549893 · 204843

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗