Chronic Subdural Hematoma3D-MMA-cSDH TrNCT07720687
Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma
A study testing Standard Burr-Hole Drainage Group and 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group in people with Chronic Subdural Hematoma, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Standard Burr-Hole Drainage Group and 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- Jan 2027to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Severe coagulation disorder or other contraindications to surgery.
- Severe systemic disease making the patient unsuitable for participation.
- Refusal or inability to provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jie Shen, MD, +8613515515154, efy126405@fy.ahmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Standard Burr-Hole Drainage Group, 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group
- Keywords
- Chronic subdural hematoma, Middle meningeal artery, Middle meningeal artery coagulation, 3D printing, Burr-hole drainage
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Burr-Hole Drainage GroupProcedure or surgery
Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.
3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation GroupProcedure or surgery
Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 3 months after surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 30 days
All-cause Mortality
All-cause Mortality: Proportion of participants who die from any cause during follow-up; reported as percentage.
Measured: Within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital
- Responsible party
- Principal investigator, Jie Shen, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720687
- Sponsor's protocol ID
- SAHAMU-CSDH-RCT-001
- Other IDs
- 202512022
- Acronym
- 3D-MMA-cSDH Tr
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07720687
- Acronym / sponsor ID
- 3D-MMA-cSDH Tr / SAHAMU-CSDH-RCT-001
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Middle meningeal artery, Middle meningeal artery coagulation, 3D printing, Burr-hole drainage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Xijing Hospital
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Burr-Hole Drainage | Active comparator | Procedure: Standard Burr-Hole Drainage GroupParticipants assigned to this arm will undergo standard burr-hole drainage for chronic subdural hematoma according to routine clinical practice. |
| 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation | Experimental | Procedure: 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Burr-Hole Drainage GroupStandard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma. | Procedure or surgery | Standard Burr-Hole Drainage |
| 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation GroupBurr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery. | Procedure or surgery | 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation |
Primary outcome
Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
Time frame: 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).
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Burr-Hole Drainage Group and 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group in people with Chronic Subdural Hematoma, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Shen, MD (+8613515515154, efy126405@fy.ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery (time frame: Within 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.