Chronic Subdural Hematoma
Conditions
Keywords
Chronic subdural hematoma, Middle meningeal artery, Middle meningeal artery coagulation, 3D printing, Burr-hole drainage
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.
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
PROCEDUREStandard Burr-Hole Drainage Group
Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.
PROCEDURE3D-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.
Sponsors
The Second Hospital of Anhui Medical University
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cSDH Recurrence (Hematoma Progression) | Within 3 months after surgery | 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. |
| Functional Outcome Measured by the Modified Rankin Scale (mRS) | Within 3 months after surgery | 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. |
| MMA identification rate | Intra-operative | Deviation between Planned and Actual Burr-hole Sites: MMA identification rate will be reported as a percentage. |
| Number of participants experiencing one or more peri-operative surgical or medical complications | Intra-operative through 30 days post-operatively | 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. |
| Length of Hospital Stay | up to 30 days | Length of Hospital Stay: Length of hospital stay is defined as the number of days from admission to discharge. |
| All-cause Mortality | Within 3 months after surgery | All-cause Mortality: Proportion of participants who die from any cause during follow-up; reported as percentage. |
Countries
China
Contacts
CONTACTJie Shen, MD
Outcome results
None listed