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

NCT07720687 | Not Yet Recruiting

• 2 other identifiers: SAHAMU-CSDH-RCT-001202512022
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Middle meningeal artery; Middle meningeal artery coagulation; 3D printing; Burr-hole drainage

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 3 months after surgery

Secondary Outcomes (6)

• Incidence of cSDH Recurrence (Hematoma Progression)

  Within 3 months after surgery

• Functional Outcome Measured by the Modified Rankin Scale (mRS)

  Within 3 months after surgery

• MMA identification rate

  Intra-operative

• Number of participants experiencing one or more peri-operative surgical or medical complications

  Intra-operative through 30 days post-operatively

• Length of Hospital Stay

  up to 30 days

Study Arms (2)

Standard Burr-Hole Drainage

ACTIVE COMPARATOR

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

3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation

EXPERIMENTAL

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

Interventions

Standard Burr-Hole Drainage Group PROCEDURE

Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.

Standard Burr-Hole Drainage

3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group PROCEDURE

Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.

3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead
• Xijing Hospital: collaborator

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

Jie Shen, MD

CONTACT

+8613515515154; efy126405@fy.ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeons and operating room staff cannot be masked because of the nature of the surgical intervention. Radiological outcome assessors, clinical outcome assessors when feasible, members of the endpoint adjudication committee, and statistical analysts will be masked to treatment allocation until the primary analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: standard burr-hole drainage or 3D-printed template-guided burr-hole drainage combined with attempted intraoperative middle meningeal artery coagulation.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be available starting in January 2027(study start date) and will remain available until June 2029 (study completion date).

Locations

CN (1)