Early Lumbar Drainage for Intraventricular Hemorrhage

Starting soon · Not applicable

Conditions studied: Intraventricular Hemorrhage, Cerebral Hemorrhage

In brief

This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial comparing the addition of early lumbar drainage to standard care in patients with intraventricular hemorrhage (IVH) in China. The primary objective is to evaluate whether early lumbar drainage improves long-term functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications in patients treated with external ventricular drainage (EVD) and intrathecal urokinase.

Key facts

Study ID

NCT07625449

Run by

Second Affiliated Hospital of Nanchang University

People needed

392

Starts

2026-06-01

Expected to finish

2029-10-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 to 85 years old, no limitation on gender.
• First-ever intracerebral hemorrhage confirmed by CT/MRI, accompanied by third and/or fourth intraventricular hemorrhage, requiring external ventricular drainage.
• Baseline hemorrhage volume less than 30 mL, with stable clinical condition before randomization.
• External ventricular drainage performed within 48 hours of symptom onset.
• Randomization completed within 24 hours after EVD placement.
• Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
• Written informed consent obtained from the participant or their legally authorized representative.

You may not qualify if…

• Suspected or untreated ruptured intracranial aneurysm, arteriovenous malformation (AVM), or intracranial tumor, unless excluded by vascular imaging. Previously treated aneurysm or AVM must have been completed at least 3 months prior to enrollment.
• Choroidal vascular malformation or moyamoya disease.
• Long-term oral anticoagulant use, persistent coagulation dysfunction, or known allergy to urokinase.
• Platelet count < 100×10⁹/L or INR > 1.4.
• Absolute contraindications to lumbar cistern drainage or external ventricular drainage, such as cerebral hernia or infection at the puncture site.
• Infratentorial hemorrhage volume ≥ 10 mL.
• Thalamic hemorrhage ≥ 10 mL, or accompanied by midbrain extension, oculomotor nerve palsy, or fixed dilated pupil.
• Hemiplegia with muscle strength grade 0 or 1.
• Active bleeding in the gastrointestinal, genitourinary, or respiratory system.
• Multiple ecchymoses or petechiae suggesting a bleeding tendency.
• Expected survival time less than 6 months.
• Severe, untreatable concomitant systemic diseases.
• Pregnancy.
• Participation in other interventional clinical trials within 30 days prior to randomization.
• Any other condition deemed inappropriate for enrollment by the investigator(s).

Where it is running

• Fuzhou First People's Hospital — Fuzhou, Jiangxi, 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

Full record on ClinicalTrials.gov

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