Chronic Subdural Hematoma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
National Hospital for Neurology and Neurosurgery
RECRUITING
London
Contact Information
Primary
Jigishaa Moudgil-Joshi, MRCS, MBChB
burrmmatrial@gmail.com
020 3456 7890
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 30
Treatments
Experimental: Burr-Hole Evacuation With CT-Guided Intra-Operative MMA Interruption
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.
Sponsors
Leads: University College, London
Collaborators: University College London Hospitals

This content was sourced from clinicaltrials.gov