Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

NCT07731620 | Not Yet Recruiting DMC

• 2 other identifiers: SAHAMU-CSDH-RCT-002202512022
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 3

Brief 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). 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.

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma; twist drill; parietal eminence puncture; frontal puncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Residual hematoma maximum thickness

  "Day 2", "Month 1", "Month3" after operation

• Residual hematoma volume

  "Day 2", "Month 1", "Month3" after operation

• Intra-cranial pneumocephalus volume

  "Day 2", "Month 1" after operation

• Improvement in midline shift

  "Day 2", "Month 1", "Month3" after operation

• Drain duration / catheter indwelling time

  immediately after the procedure

Study Arms (2)

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.

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.

Procedure: Parietal Eminence region puncture drainage

Interventions

Frontal-region puncture drainage PROCEDURE

Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).

Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage)

Parietal Eminence region puncture drainage PROCEDURE

Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

Parietal Eminence Burr Hole Puncture Group(twist-drill drainage)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Life expectancy \< 6 months.
• Pregnancy.
• Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead
• Yangzhou University: collaborator
• Huai'an First People's Hospital: collaborator

Study Sites (3)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Huai'an First People's Hospital

Huai'an, Jiangsu, 223300, China

Location

Yangzhou University Affiliated Hospital

Yangzhou, Jiangsu, 225009, 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

Study Officials

• qi li, MD

  The Second Hospital of Anhui Medical University

  STUDY DIRECTOR

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: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)