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NCT07625449
NA

Early Lumbar Drainage for Intraventricular Hemorrhage

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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