Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma
Starting soon · Not applicable
Conditions studied: Chronic Subdural Hematoma
In brief
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.
Key facts
- Study ID
- NCT07731620
- Run by
- The Second Hospital of Anhui Medical University
- People needed
- 440
- Starts
- 2027-01-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
- Huai'an First People's Hospital — Huai'an, Jiangsu, China
- Yangzhou University Affiliated Hospital — Yangzhou, Jiangsu, China
Full record on ClinicalTrials.gov
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