Early Lumbar Drainage for Intraventricular Hemorrhage
LD-IVH
Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial
2 other identifiers
interventional
392
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
June 4, 2026
May 1, 2026
3.3 years
May 16, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with mRS score 0-3 at 180 days after onset
Percentage of patients with modified Rankin Scale score 0 to 3 at 180-day follow-up.
180 days after disease onset
Secondary Outcomes (9)
Proportion of participants with mRS 0-3 at 90 days after onset
90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
90 days, 180 days after onset
Ordinal change of mRS score from baseline to 180 days
Baseline to 180 days
EQ-5D health utility score at 180 days
180 days after onset
- +4 more secondary outcomes
Other Outcomes (3)
All-cause mortality at 90 days and 180 days
90 days, 180 days after onset
Incidence of bacterial ventriculitis or meningitis
During treatment and 180-day follow-up
Incidence of cerebral hernia
Perioperative period
Study Arms (2)
Control Group (EVD + Intrathecal Urokinase)
ACTIVE COMPARATORPatients receive external ventricular drainage combined with intrathecal urokinase injection. Single dose 30,000 IU per day for continuous 3 days, and the maximum duration of urokinase treatment shall not exceed 5 days. Discontinue medication when third/fourth ventricular clot clearance, relieved mass effect, or hematoma clearance rate ≥80% on cranial CT.
Intervention Group (EVD + Urokinase + Early Lumbar Cistern Drainage)
EXPERIMENTALOn the basis of the same EVD and intrathecal urokinase regimen as the control group, early lumbar drainage is performed within 24 hours. CSF drainage speed is controlled below 8 mL/h, and daily total drainage volume does not exceed 200 mL to maintain stable intracranial pressure.
Interventions
Early lumbar cistern drainage is performed within 24 hours. CSF drainage speed is controlled below 8 mL/h, and daily total drainage volume does not exceed 200 mL to maintain stable intracranial pressure.
Patients receive external ventricular drainage combined with intrathecal urokinase injection. Single dose 30,000 IU per day for continuous 3 days; the maximum duration of urokinase treatment shall not exceed 5 days. Discontinue medication when third/fourth ventricular clot clearance, relieved mass effect, or hematoma clearance rate ≥80% on cranial CT.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shigang Lv, MD
Second Affiliated Hospital of Nanchang University
- PRINCIPAL INVESTIGATOR
Miaojing Wu, MD
Second Affiliated Hospital of Nanchang University
- STUDY CHAIR
Xingen Zhu, Prof
Second Affiliated Hospital of Nanchang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2026
First Posted
June 4, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share