Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Frontal-region puncture drainage; Procedure: Parietal Eminence region puncture drainage

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 Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jie shen, MD; Phone Number: +8613515515154; Email: efy126405@fy.ahmu.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Jie Shen, MD; Phone Number: +8613515515154
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Huai'an first people's hospital
      • Contact: Quan Chen, Dr; Phone Number: 86+13852346565; Email: 13852346565@163.com
    • Yangzhou, Jiangsu, China, 225009
      • Yangzhou University Affiliated Hospital
      • Contact: Chun Xiao Duan, Dr; Phone Number: 86+13852703561; Email: doctor_duan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.

4. 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.

5. Plan to undergo twist-drill puncture drainage with a closed drainage system.
6. Written informed consent signed by the participant or their legally authorized representative.

Exclusion Criteria:

1. Bilateral cSDH requiring simultaneous bilateral surgery.
2. Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
3. Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
4. Previous surgery on the ipsilateral side for cSDH.
5. Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
6. Severe coagulation disorder that cannot be corrected before surgery.
7. Life expectancy < 6 months.
8. Pregnancy.
9. Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage); 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.	Procedure: Frontal-region puncture drainage; Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Active Comparator: Parietal Eminence Burr Hole Puncture Group(twist-drill drainage); 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.	Procedure: Parietal Eminence region puncture drainage; Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual hematoma maximum thickness	Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.	"Day 2", "Month 1", "Month3" after operation
Residual hematoma volume	Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.	"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).	"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.	"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.	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.	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.	"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.	"Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation	Death from any cause assessed at 3 months after surgery.	From operation up to 3 months postoperatively

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Collaborators: Yangzhou University; Huai'an First People's Hospital
• Investigators: Study Director: qi li, MD, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 25, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 25, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: chronic subdural hematoma; twist drill; parietal eminence puncture; frontal puncture
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: SAHAMU-CSDH-RCT-002; 202512022 (Other Grant/Funding Number: Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No