An interventional study of Standard Burr-Hole Drainage Group and 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group in Chronic Subdural Hematoma, sponsored by The Second Hospital of Anhui Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Treatment
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.
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.
Inclusion Criteria
Participants assigned to this arm will undergo standard burr-hole drainage for chronic subdural hematoma according to routine clinical practice.
Procedure: Standard Burr-Hole Drainage Group
Participants assigned to this arm will undergo 3D-printed template-guided burr-hole drainage combined with attempted intraoperative middle meningeal artery coagulation for chronic subdural hematoma.
Procedure: 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group
Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.
Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.
Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
Recurrence is defined as radiologically confirmed recurrent chronic subdural hematoma requiring repeat surgical intervention within 3 months after the initial surgery (e.g., repeat burr-hole drainage, craniotomy, endoscopic treatment, and/or MMA embolization).
Time frame: Within 3 months after surgery
Incidence of cSDH Recurrence (Hematoma Progression)
Incidence of cSDH Recurrence (Hematoma Progression): Hematoma progression will be defined as radiological increase in ipsilateral and/or bilateral subdural hematoma on follow-up imaging compared with the predefined postoperative baseline. Hematoma progression (Yes/No) will be considered present if any of the following criteria are met: (1) increase in maximal subdural hematoma thickness by ≥ 5 mm; (2) increase in midline shift by ≥ 3 mm; or (3) increase in hematoma cavity volume by ≥ 25%. The incidence will be reported as a percentage.
Time frame: Within 3 months after surgery
Functional Outcome Measured by the Modified Rankin Scale (mRS)
Functional Outcome Measured by the Modified Rankin Scale (mRS): Functional status will be measured using the Modified Rankin Scale (mRS), a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcome.
Time frame: Within 3 months after surgery
MMA identification rate
Deviation between Planned and Actual Burr-hole Sites: MMA identification rate will be reported as a percentage.
Time frame: Intra-operative
Number of participants experiencing one or more peri-operative surgical or medical complications
Incidence of Peri-Operative Complications：Number of participants experiencing one or more peri-operative surgical or medical complications (e.g., wound infection, seizure, pneumonia, venous thromboembolism, acute subdural haematoma). Reported as a count and percentage.
Time frame: Intra-operative through 30 days post-operatively
Length of Hospital Stay
Length of Hospital Stay: Length of hospital stay is defined as the number of days from admission to discharge.
Time frame: up to 30 days
All-cause Mortality
All-cause Mortality: Proportion of participants who die from any cause during follow-up; reported as percentage.
Time frame: Within 3 months after surgery
Plan to share: Yes — We will share the individual participant data (IPD) underlying the results, including de-identified participant data: Participant-level data: baseline characteristics and pre-specified outcome Outcome data: all measures used for the primary and secondary endpoints Study data files: datasets used for the statistical analyses (e.g., analysis-ready datasets and relevant derived variables)
Supporting information: Study protocol, Sap, Icf, Csr
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The Second Hospital of Anhui Medical University