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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CT-Guided Intra-Operative Middle Meningeal Artery Interruption

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

University College, London

Lead sponsor

University College London Hospitals

Collaborator