Status:
NOT_YET_RECRUITING
Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. T...
Detailed Description
Chronic subdural hematoma (CSDH) is a common disease in neurosurgery. It is generally considered to be a closed fluid collection situated between the dura mater and arachnoid mater, formed by blood or...
Eligibility Criteria
Inclusion
- Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- CSDH verified on cranial computed tomography or magnetic resonance imaging.
- Written informed consent from patients or their next of kin according to the patient's cognitive status.
Exclusion
- No clinical symptoms correlating with chronic subdural hematoma.
- Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.
- Previous surgery for CSDH during the past 6 months.
- Previous intracranial surgery for any other neurological disorder.
- Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.
- Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L).
- Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.
- Reproductive-age women without verified negative pregnancy testing.
- Participating in another research.
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT07144423
Start Date
August 31 2025
End Date
December 31 2026
Last Update
August 27 2025
Active Locations (24)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
2
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
3
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529030
4
Shantou central hosital
Shantou, Guangdong, China, 515031