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Clinical Trials in China / NCT07625449
Starting soon Not applicable

Early Lumbar Drainage for Intraventricular Hemorrhage

NCT07625449 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Nanchang University
Phase
Not applicable
Started
2026-10
Last updated
2026-09-04

Condition(s) studied

Intraventricular HemorrhageCerebral Hemorrhage

Investigational drug(s) / intervention(s)

Control treatment plus lumbar drainageControl treatment schedule

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%.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18-85 years, of either sex. 2. First-ever intracerebral hemorrhage (ICH) with CT-confirmed hemorrhage involving the third and/or fourth ventricle, and scheduled to undergo or already having undergone burr-hole ventricular drainage. 3. Intraparenchymal hemorrhage volume \<30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization. 4. Randomization completed within 72 hours of symptom onset. 5. Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities). 6. Written informed consent obtained from the participant or a legal guardian. Exclusion Criteria: 1. Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor. 2. Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase. 3. Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal. 4. Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site). 5. Infratentorial hemorrhage with a volume ≥10 mL. 6. Thalamic hemorrhage with a volume ≥10 mL, or accompanied by obvious extension into the midbrain, oculomotor nerve palsy, or fixed and dilated non-reactive pupils. 7. Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization. 8. Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts. 9. Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency. 10. Expected survival of less than 6 months due to other causes. 11. Other coexisting severe diseases that are difficult to treat. 12. Pregnancy. 13. Participation in another interventional clinical trial within 30 days before randomization. 14. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Fuzhou First People's Hospital Fuzhou Jiangxi
Jinan Central Hospital Jinan Shandong
Taizhou Hospital of Zhejiang Province Taizhou Zhejiang
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

More Second Affiliated Hospital of Nanchang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625449 on ClinicalTrials.gov ↗ ← All trials in China