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Early Lumbar Drainage for Intraventricular Hemorrhage
Sponsor: Second Affiliated Hospital of Nanchang University
Summary
This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial in Chinese patients with intraventricular hemorrhage (IVH), comparing early lumbar drainage added to standard care with standard care alone. The primary objective is to evaluate whether, in patients treated with external ventricular drainage (EVD) and intrathecal urokinase, the addition of early lumbar drainage improves functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications.
Official title: Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
392
Start Date
2026-10
Completion Date
2029-10
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Control treatment plus lumbar drainage
Early lumbar cistern drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure.
Control treatment schedule
Patients receive external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase is administered as a single daily dose of 30,000 IU for 3 consecutive days, and the maximum duration of urokinase treatment does not exceed 5 days. Thrombolysis is discontinued when cranial CT demonstrates clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
Locations (31)
Fuzhou First People's Hospital
Fuzhou, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Changde First People's Hospital
Changde, China
Lingcheng District People's Hospital
Dezhou, China
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, China
Ganzhou People's Hospital
Ganzhou, China
Ruijin People's Hospital
Ganzhou, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Jingdezhen Second People's Hospital
Jingdezhen, China
Jiujiang First People's Hospital
Jiujiang, China
The First People's Hospital of Xiushui County
Jiujiang, China
Ji'an Central People's Hospital
Ji’an, China
The Second Hospital of Lanzhou University
Lanzhou, China
Linyi People's Hospital
Linyi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, China
Nanchang Central Hospital
Nanchang, China
Second Affiliated Hospital of Nanchang University
Nanchang, China
Panzhihua Central Hospital
Panzhihua, China
Taihe Hospital
Shiyan, China
The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Suzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Yichang Central People's Hospital
Yichang, China
Zhangshu People's Hospital
Yichun, China
Yingtan People's Hospital
Yingtan, China
Zhangjiagang First People's Hospital
Zhangjiagang, China
Zhoukou Central Hospital
Zhoukou, China
Zunyi First People's Hospital
Zunyi, China