Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

Recruiting now · Not applicable

Conditions studied: Chronic Subdural Hematoma

In brief

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.

Key facts

Study ID

NCT07144423

Run by

Beijing Tiantan Hospital

People needed

770

Starts

2025-11-19

Expected to finish

2027-12-31

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (enrolling)
• Shantou central hosital — Shantou, Guangdong, China (enrolling)
• People's Hospital of Longhua, Shenzhen — Shenzhen, Guangdong, China (enrolling)
• Liuzhou worker's Hospital — Liuzhou, Guangxi, China (enrolling)
• The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Nanning First People's Hospital — Nanning, Guangxi, China (enrolling)
• The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine — Nanning, Guangxi, China (enrolling)
• Wuzhou Gongren Hospital — Wuzhou, Guangxi, China (enrolling)
• Hebei University of Engineering Affiliated Hospital — Handan, Hebei, China (enrolling)
• Xingtai Central Hospital — Xingtai, Hebei, China (enrolling)
• Changde First People's Hospital — Changde, Hunan, China (enrolling)
• People's Hospital of Xiangxi Prefecture, Hunan Province — Jishou, Hunan, China (enrolling)
• Yueyang Central Hospital — Yueyang, Hunan, China (enrolling)
• Heji Hospital affiliated with Changzhi Medical College — Changzhi, Shanxi, China (enrolling)
• Linfen People's Hospital — Linfen, Shanxi, China (enrolling)
• Shanxi Provincial People's Hospital,Shanxi Medical University — Taiyuan, Shanxi, China (enrolling)
• The Second Affiliated Hospital of Xi'an Medical University — Xi’an, Shanxi, China (enrolling)
• Mianyang 404 Hospital — Mianyang, Sichuan, China (enrolling)
• the First People'S Hospital of Yibin — Yibin, Sichuan, China (enrolling)
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (enrolling)
• Pu'er People's Hospital — Pu'er, Yunnan, China (enrolling)
• First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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