Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

NCT07731620 · tracked via the Priya Life Science China tracker

Sponsor

The Second Hospital of Anhui Medical University

Phase

Not applicable

Started

2027-01

Last updated

2026-07-28

Condition(s) studied

Chronic Subdural Hematoma

Investigational drug(s) / intervention(s)

Frontal-region puncture drainageParietal Eminence region puncture drainage

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery — 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.

Trial sites (3)

Facility	City	Region
The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
Huai'an First People's Hospital	Huai'an	Jiangsu
Yangzhou University Affiliated Hospital	Yangzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07731620 on ClinicalTrials.gov ↗ ← All trials in China