Chronic Subdural HematomaNCT07731620
Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma
A study testing Frontal-region puncture drainage and Parietal Eminence region puncture drainage in people with Chronic Subdural Hematoma, run by The Second Hospital of Anhui Medical University at 3 sites in China.
Trial summary
This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH). 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?
- Frontal-region puncture drainage and Parietal Eminence region puncture drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 3 sitesChina
- 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
- Age ≥ 18 years.
- Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
- Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.
- Radiological indication for surgery, defined as one of the following:
- Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.
- Plan to undergo twist-drill puncture drainage with a closed drainage system.
- Written informed consent signed by the participant or their legally authorized representative.
Who cannot join
- Bilateral cSDH requiring simultaneous bilateral surgery.
- Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
- Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
- Previous surgery on the ipsilateral side for cSDH.
- Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
- Severe coagulation disorder that cannot be corrected before surgery.
Show all 9Show fewer
- Life expectancy < 6 months.
- Pregnancy.
- Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jie Shen, MD, +8613515515154
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300
Quan Chen, Dr, 86+13852346565, 13852346565@163.com
Yangzhou University Affiliated Hospital
Yangzhou, Jiangsu, 225009
Chun Xiao Duan, Dr, 86+13852703561, doctor_duan@163.com
About this study
Official title: Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma
This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH).
The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI).
Read more
The main questions this study is designed to answer are:
- Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months
- Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures)
There are two groups, researchers will compare:
- Group A: patients receiving puncture at the frontal region vs.
- Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other.
Participants will:
- undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence;
- receive closed-system drainage after a twist-drill puncture;
- complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence;
- have safety monitoring throughout the study period to record any complications or adverse events.
Read the detailed description
This is a (multi-center) prospective, randomized, parallel-group, assessor-blinded clinical trial in eligible patients with unilateral chronic subdural hematoma (cSDH) to compare the effects of puncture-site location on outcomes after minimally invasive drainage: participants will be randomly assigned 1:1 to Group A (frontal twist-drill puncture drainage) or Group B (parietal eminence twist-drill puncture drainage), with both groups receiving standardized closed-system subdural drainage and postoperative management; random allocation will be concealed using a secure electronic randomization system or sealed opaque envelopes prepared by a researcher not involved in surgery or outcome assessment. The primary outcome is the rate of ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (recurrence defined as symptomatic re-accumulation or enlargement confirmed by imaging and judged by the treating team to require repeat intervention). Secondary outcomes include postoperative residual hematoma maximum thickness and volume at 24-48 hours, pneumocephalus volume at 24-48 hours, reduction in midline shift, brain re-expansion rate, drainage duration, length of hospital stay, postoperative complications, Markwalder grading and modified Rankin Scale (mRS) scores at 30 days/3 months, and mortality at 30 days and 3 months; although surgeon blinding is not feasible, radiological and clinical outcome assessors and statisticians will be blinded whenever possible, with anonymized postoperative CT images assessed independently by trained reviewers.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Frontal-region puncture drainage, Parietal Eminence region puncture drainage
- Keywords
- chronic subdural hematoma, twist drill, parietal eminence puncture, frontal puncture
- 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.
Frontal-region puncture drainageProcedure or surgery
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Parietal Eminence region puncture drainageProcedure or surgery
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.
| Study group | Role | What they receive |
|---|---|---|
| Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage) | Experimental | The puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment. Receives: Procedure: Frontal-region puncture drainage |
| Parietal Eminence Burr Hole Puncture Group(twist-drill drainage) | Active comparator | The puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment. Receives: Procedure: Parietal Eminence region puncture drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
Measured: 3 months
Secondary outcomes (9)
Residual hematoma maximum thickness
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
Measured: "Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
Measured: "Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
Measured: "Day 2", "Month 1" after operation
Improvement in midline shift
Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement.
Measured: "Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
Time from catheter placement to catheter removal, reported as hours/days per protocol.
Measured: immediately after the procedure
Postoperative complications
Any adverse events occurring postoperatively, including (but not limited to):
acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement.
Measured: From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points.
Measured: "Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
Functional status measured by mRS at the specified follow-up time points.
Measured: "Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
Death from any cause assessed at 3 months after surgery.
Measured: From operation up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 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
- Randomized, controlled, parallel-group clinical trial; participants assigned 1:1 to two intervention arms (frontal vs parietal eminence puncture site) using minimally invasive burr-hole drainage with closed-system drainage; outcome assessors blinded where feasible.
- 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
- Yangzhou University, Huai'an First People's Hospital
- Responsible party
- Principal investigator, Jie Shen, The Second Hospital of Anhui Medical University
- Investigators
- qi li, MD, Study director, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731620
- Sponsor's protocol ID
- SAHAMU-CSDH-RCT-002
- Other IDs
- 202512022
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT07731620
- Acronym / sponsor ID
- SAHAMU-CSDH-RCT-002
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, twist drill, parietal eminence puncture, frontal puncture
- 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
- Yangzhou University, Huai'an First People's Hospital
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 28 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.
This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH).
The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI).
The main questions this study is designed to answer are:
- Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months
- Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures)
There are two groups, researchers will compare:
- Group A: patients receiving puncture at the frontal region vs.
- Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other.
Participants will:
- undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence;
- receive closed-system drainage after a twist-drill puncture;
- complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence;
- have safety monitoring throughout the study period to record any complications or adverse events.
Detailed description
This is a (multi-center) prospective, randomized, parallel-group, assessor-blinded clinical trial in eligible patients with unilateral chronic subdural hematoma (cSDH) to compare the effects of puncture-site location on outcomes after minimally invasive drainage: participants will be randomly assigned 1:1 to Group A (frontal twist-drill puncture drainage) or Group B (parietal eminence twist-drill puncture drainage), with both groups receiving standardized closed-system subdural drainage and postoperative management; random allocation will be concealed using a secure electronic randomization system or sealed opaque envelopes prepared by a researcher not involved in surgery or outcome assessment. The primary outcome is the rate of ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (recurrence defined as symptomatic re-accumulation or enlargement confirmed by imaging and judged by the treating team to require repeat intervention). Secondary outcomes include postoperative residual hematoma maximum thickness and volume at 24-48 hours, pneumocephalus volume at 24-48 hours, reduction in midline shift, brain re-expansion rate, drainage duration, length of hospital stay, postoperative complications, Markwalder grading and modified Rankin Scale (mRS) scores at 30 days/3 months, and mortality at 30 days and 3 months; although surgeon blinding is not feasible, radiological and clinical outcome assessors and statisticians will be blinded whenever possible, with anonymized postoperative CT images assessed independently by trained reviewers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel-group clinical trial; participants assigned 1:1 to two intervention arms (frontal vs parietal eminence puncture site) using minimally invasive burr-hole drainage with closed-system drainage; outcome assessors blinded where feasible.
| Arm | Type | Receives |
|---|---|---|
| Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage) | Experimental | Procedure: Frontal-region puncture drainageThe puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment. |
| Parietal Eminence Burr Hole Puncture Group(twist-drill drainage) | Active comparator | Procedure: Parietal Eminence region puncture drainageThe puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
- Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.
- Radiological indication for surgery, defined as one of the following:
- Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.
Key exclusion criteria (9 listed)
- Bilateral cSDH requiring simultaneous bilateral surgery.
- Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
- Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
- Previous surgery on the ipsilateral side for cSDH.
- Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
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 |
|---|---|---|
| Frontal-region puncture drainagePatients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH). | Procedure or surgery | Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage) |
| Parietal Eminence region puncture drainagePatients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH. | Procedure or surgery | Parietal Eminence Burr Hole Puncture Group(twist-drill drainage) |
Primary outcome
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Time frame: 3 months
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
9 secondary outcomes
Residual hematoma maximum thickness
Time frame: "Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
Time frame: "Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
Time frame: "Day 2", "Month 1" after operation
Improvement in midline shift
Time frame: "Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
Time frame: immediately after the procedure
Postoperative complications
Time frame: From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
Time frame: "Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
Time frame: "Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
Time frame: From operation up to 3 months postoperatively
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
qi li, MD study director
The Second Hospital of Anhui Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frontal-region puncture drainage and Parietal Eminence region puncture drainage in people with Chronic Subdural Hematoma, run by The Second Hospital of Anhui Medical University at 3 sites 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 7 inclusion and 9 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 28 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 3 sites 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?
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (time frame: 3 months). 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 28 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.