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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• National Hospital for Neurology and Neurosurgery — London

Идентификаторы

NCT: NCT07549893 · 204843

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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