Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma

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Conditions studied: Chronic Subdural Hematoma

In brief

Chronic subdural hematoma is a collection of blood and fluid on the surface of the brain that is common in older adults. Burr-hole drainage is a standard surgical treatment, but the hematoma may come back in some patients and require another procedure.This study will test whether using a patient-specific 3D-printed template to guide burr-hole placement, combined with coagulation of the middle meningeal artery during surgery, can reduce the risk of hematoma recurrence compared with standard burr-hole drainage.Participants with symptomatic chronic subdural hematoma who need surgery will be randomly assigned to one of two groups. One group will receive standard burr-hole drainage. The other group will receive 3D-printed template-guided burr-hole drainage with attempted intraoperative frontal branch of the middle meningeal artery coagulation when it can be safely performed.The main outcome is whether the hematoma comes back and requires another invasive treatment within 3 months after surgery. The study will also assess brain imaging results, neurological recovery, complications, hospital stay, and the feasibility and safety of the 3D-printed template and artery coagulation procedure.

Key facts

Study ID

NCT07720687

Run by

The Second Hospital of Anhui Medical University

People needed

440

Starts

2027-01-01

Expected to finish

2029-06-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with chronic subdural hematoma based on clinical symptoms and cranial CT or MRI.
• Patients scheduled to undergo burr-hole drainage surgery.
• Age 18 years or older.
• Written informed consent obtained from the patient or legal representative. Exclusion Criteria
• Acute subdural hematoma or other intracranial lesions requiring different surgical management.
• Previous surgery for the same episode of chronic subdural hematoma.
• Severe coagulation disorder or other contraindications to surgery.
• Severe systemic disease making the patient unsuitable for participation.
• Refusal or inability to provide informed consent.

Where it is running

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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