Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Burr-Hole Drainage Group, 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Three-Dimensional Printed Template-Guided Burr-Hole Drainage Combined With Intraoperative Middle Meningeal Artery Coagulation for Preventing Recurrence of Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial
Overview
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.
Detailed description
Chronic subdural hematoma is a common neurosurgical disease, especially in older adults. Burr-hole drainage with closed-system drainage is widely used as standard surgical treatment. However, recurrence after surgery remains an important clinical problem and may require repeat invasive treatment.
The middle meningeal artery is believed to contribute to the blood supply of the outer membrane of chronic subdural hematoma. Interruption of middle meningeal artery flow may reduce repeated microbleeding and fluid exudation from the hematoma membrane. Endovascular middle meningeal artery embolization has shown promising results, but it requires angiographic equipment, interventional expertise, embolic materials, and additional cost.
This study evaluates a surgical strategy that combines patient-specific 3D-printed template guidance with burr-hole drainage and intraoperative middle meningeal artery coagulation. Preoperative thin-slice computed tomography images will be used to plan the burr-hole location and design a 3D-printed template. The template is intended to help surgeons locate a burr-hole site related to the expected course of the middle meningeal artery(frontal branch) while still allowing effective hematoma drainage.
Participants with symptomatic chronic subdural hematoma requiring burr-hole drainage will be randomly assigned to receive either standard burr-hole drainage or 3D-printed template-guided burr-hole drainage with attempted intraoperative middle meningeal artery coagulation when safely feasible.
The study will test whether this approach can reduce recurrence requiring repeat invasive treatment within 3 months after surgery. It will also assess clinical recovery, radiological changes, complications, resource use, and the feasibility and safety of template-guided localization and intraoperative artery coagulation.Patient safety will take priority over completion of the coagulation step. If the middle meningeal artery or a related branch cannot be clearly identified or safely coagulated during surgery, coagulation will not be performed, and standard hematoma drainage will be completed.
Interventions
- Procedure Standard Burr-Hole Drainage Group
Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma. - Procedure 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group
Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.
Primary outcome measures
- Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery [Time frame: Within 3 months after surgery]
Secondary outcome measures (6)
- Incidence of cSDH Recurrence (Hematoma Progression) [Time frame: Within 3 months after surgery]
- Functional Outcome Measured by the Modified Rankin Scale (mRS) [Time frame: Within 3 months after surgery]
- MMA identification rate [Time frame: Intra-operative]
- Number of participants experiencing one or more peri-operative surgical or medical complications [Time frame: Intra-operative through 30 days post-operatively]
- Length of Hospital Stay [Time frame: up to 30 days]
- All-cause Mortality [Time frame: Within 3 months after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Anhui Medical University — Hefei
Identifiers
NCT: NCT07720687 · SAHAMU-CSDH-RCT-001 · 202512022