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
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Typical duration for not_applicable
31 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
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedStudy Start
First participant enrolled
October 1, 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
September 4, 2026
March 1, 2026
3 years
May 16, 2026
September 1, 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 (13)
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 and 180 days after disease onset
Change in ordinal mRS score from baseline to 180 days after onset
Baseline to 180 days after disease onset
EQ-5D score at 180 days after onset
180 days after disease onset
- +8 more secondary outcomes
Other Outcomes (5)
All-cause mortality at 180 days after onset
180 days after disease onset
Proportion of participants with intracranial infection
From enrollment through hospital discharge
Proportion of participants with cerebral herniation
From enrollment through hospital discharge
- +2 more other outcomes
Study Arms (2)
Control Group (EVD + Intrathecal Urokinase)
ACTIVE COMPARATORPatients received external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase was administered as a single daily dose of 30,000 IU for 3 consecutive days. A follow-up cranial CT was then performed to assess ventricular obstruction and hematoma clearance, which guided the decision on whether to continue thrombolysis. The maximum total duration of urokinase treatment did not exceed 5 days. Thrombolysis was discontinued when CT demonstrated clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
Intervention Group (Control Treatment + Lumbar Drainage)
EXPERIMENTALIn addition to the same EVD and intrathecal urokinase regimen as the control group, early lumbar 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.
Interventions
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.
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%.
Eligibility Criteria
You may qualify if:
- Aged 18-85 years, of either sex.
- 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.
- Intraparenchymal hemorrhage volume \<30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization.
- Randomization completed within 72 hours of symptom onset.
- Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities).
- Written informed consent obtained from the participant or a legal guardian.
You may not qualify if:
- Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor.
- Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase.
- Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal.
- Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site).
- Infratentorial hemorrhage with a volume ≥10 mL.
- 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.
- Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization.
- Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts.
- Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency.
- Expected survival of less than 6 months due to other causes.
- Other coexisting severe diseases that are difficult to treat.
- Pregnancy.
- Participation in another interventional clinical trial within 30 days before randomization.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
- PRINCIPAL INVESTIGATOR
Zeguang Ren, Prof
Methodist Houston Sugar Land Hospital
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
October 1, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
September 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share