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

NCT07549893 | Not Yet Recruiting DMC

• 1 other identifier: 204843
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Subdural Hematomas

Keywords

chronic subdural haematoma; middle meningeal artery; burrholes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  At 90 days post-operatively.

Secondary Outcomes (11)

• Incidence of cSDH Recurrence Requiring Re-Intervention

  Up to 90 days post-operatively

• Length of Hospital Stay

  During index admission (up to discharge, assessed up to 90 days post-operatively).

• Incidence of Peri-Operative Complications

  Intra-operative through 30 and 90 days post-operatively.

• Incidence of Unplanned Hospital Readmission

  From discharge through 90 days post-operatively.

• Functional Outcome Measured by the Modified Rankin Scale (mRS)

  At 90 days post-operatively.

Study Arms (1)

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.

Procedure: CT-Guided Intra-Operative Middle Meningeal Artery Interruption

Interventions

CT-Guided Intra-Operative Middle Meningeal Artery Interruption PROCEDURE

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.

Also known as: MMA coagulation during burr-hole surgery, Intra-operative MMA interruption

Burr-Hole Evacuation With CT-Guided Intra-Operative MMA Interruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

Jigishaa Moudgil-Joshi, MRCS, MBChB

CONTACT

020 3456 7890; burrmmatrial@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6-12 months following publication of the primary study results and will remain available for up to 5 years thereafter, subject to data governance and sponsor approval.
• Access Criteria: Access will be provided to researchers with a methodologically sound proposal that is consistent with the aims of the original study. Requests will be reviewed by the study team and Sponsor. Data will be shared under a formal data sharing agreement and in accordance with applicable data protection regulations. Access will be limited to de-identified data and may be provided via secure institutional platforms.