NCT07144423 Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma
| NCT ID | NCT07144423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 770 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 770 participants in total. It began in 2025-11-19 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.
Eligibility Criteria
Inclusion Criteria: 1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. 2. CSDH verified on cranial computed tomography or magnetic resonance imaging. 3. Written informed consent from patients or their next of kin according to the patient's cognitive status. Exclusion Criteria: 1. No clinical symptoms correlating with chronic subdural hematoma. 2. Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons. 3. Previous surgery for CSDH during the past 6 months. 4. Previous intracranial surgery for any other neurological disorder. 5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed. 6. 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). 7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit. 8. Reproductive-age women without verified negative pregnancy testing. 9. Participating in another research.
Contact & Investigator
Guoyi Gao, MD
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT07144423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07144423 currently recruiting?
Yes, NCT07144423 is actively recruiting participants. Contact the research team at jasewl@sina.com for enrollment information.
Where is the NCT07144423 trial being conducted?
This trial is being conducted at Beijing, China, Xiamen, China, Jiangmen, China, Shantou, China and 11 additional locations.
Who is sponsoring the NCT07144423 clinical trial?
NCT07144423 is sponsored by Beijing Tiantan Hospital. The principal investigator is Guoyi Gao, MD at Beijing Tiantan Hospital. The trial plans to enroll 770 participants.