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

RecruitingNAAges 18 Years - anyAllUniversity College, London
NCT07549893 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
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.
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What it tests

  • CT-Guided Intra-Operative Middle Meningeal Artery Interruption
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Where

1 site
National Hospital for Neurology and Neurosurgery
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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