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Not Yet Recruiting NCT07731620

Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

Conditions: Chronic Subdural Hematoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 440
Sponsor: The Second Hospital of Anhui Medical University

Location: The Second Affiliated Hospital of Anhui Medical University Hefei Anhui

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 Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07731620). StuddyBuddy aggregates publicly available trial information.