Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

June 3, 2026 updated by: Second Affiliated Hospital of Nanchang University

Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraventricular hemorrhage (IVH) is a life-threatening complication of acute stroke, associated with high rates of mortality and severe disability, fewer than 20% of survivors achieve favorable functional outcomes. Despite widespread use of external ventricular drainage (EVD) and intraventricular thrombolysis, the role of early lumbar drainage in improving outcomes remains controversial, with limited high-level evidence from randomized controlled trials.

This study uses a 1:1 stratified block randomization design, with stratification by the etiology of IVH, site of ventricular obstruction, and participating center. Eligible patients will be randomized to receive either:

Control group: Standard treatment with EVD plus daily intrathecal urokinase (30,000 IU) for up to 3 to 5 days.

Intervention group: The same standard EVD and urokinase regimen, plus early lumbar drainage initiated within 24 hours of EVD placement. Drainage will be titrated to a rate ≤8 mL/h, with a maximum daily volume of 200 mL, to maintain stable intracranial pressure.

The primary endpoint is the proportion of patients with a favorable functional outcome (mRS 0-3) at 180 days. Secondary endpoints include 90-day functional status, incidence of post-hemorrhagic hydrocephalus, hospital length of stay, and mortality. Safety endpoints include all-cause mortality, intracranial infection, and cerebral herniation. A total of 392 patients will be enrolled, with an interim efficacy analysis planned when 50% of participants complete their 180-day follow-up.

Study Type

Interventional

Enrollment (Estimated)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Changde, China
        • Changde First People's Hospital
        • Contact:
      • Dezhou, China
      • Dezhou, China
      • Ganzhou, China
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • The First Affiliated Hospital of Gannan Medical University
          • Email: zzbbchina@126.com
      • Ganzhou, China
      • Ganzhou, China
        • Ruijin People's Hospital
        • Contact:
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
          • The Affiliated Hospital of Guizhou Medical University
          • Email: yhmed@163.com
      • Hangzhou, China
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • The First Affiliated Hospital of Zhejiang University School of
          • Email: gujun66@163.com
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Jingdezhen, China
        • Jingdezhen Second People's Hospital
        • Contact:
      • Jiujiang, China
        • Jiujiang First People's Hospital
        • Contact:
      • Jiujiang, China
        • The First People's Hospital of Xiushui County
        • Contact:
      • Ji’an, China
        • Ji'an Central People's Hospital
        • Contact:
      • Lanzhou, China
        • The Second Hospital of Lanzhou University
        • Contact:
      • Linyi, China
      • Luzhou, China
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
          • The Affiliated Hospital of Southwest Medical University
          • Email: yhmed@163.com
      • Nanchang, China
        • Second Affiliated Hospital of Nanchang University
        • Contact:
          • Second Affiliated Hospital of Nanchang University
          • Phone Number: +86 13097286794
          • Email: hp666edu@163.com
      • Nanchang, China
        • Nanchang Central Hospital
        • Contact:
      • Panzhihua, China
      • Shiyan, China
      • Suzhou, China
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • Contact:
      • Wenzhou, China
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • The Second Affiliated Hospital of Wenzhou Medical University
          • Email: shs951052@163.com
      • Yichang, China
        • Yichang Central People's Hospital
        • Contact:
      • Yichun, China
        • Zhangshu People's Hospital
        • Contact:
      • Yingtan, China
        • Yingtan People's Hospital
        • Contact:
      • Zhangjiagang, China
        • Zhangjiagang First People's Hospital
        • Contact:
      • Zhoukou, China
        • Zhoukou Central Hospital
        • Contact:
      • Zunyi, China
        • Zunyi First People's Hospital
        • Contact:
    • Jiangxi
      • Fuzhou, Jiangxi, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group (EVD + Intrathecal Urokinase)
Patients 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.
Procedure: External ventricular drainage plus Intrathecal Urokinase
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.
Experimental: Intervention Group (EVD + Urokinase + Early Lumbar Cistern Drainage)
On 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.
Procedure: Lumbar Drainage combined with external ventricular drainage plus Intrathecal Urokinase
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with mRS score 0-3 at 180 days after onset
Time Frame: 180 days after disease onset
Percentage of patients with modified Rankin Scale score 0 to 3 at 180-day follow-up.
180 days after disease onset

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with mRS 0-3 at 90 days after onset
Time Frame: 90 days after onset
90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
Time Frame: 180 days after onset
180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
Time Frame: 90 days, 180 days after onset
90 days, 180 days after onset
Ordinal change of mRS score from baseline to 180 days
Time Frame: Baseline to 180 days
Baseline to 180 days
EQ-5D health utility score at 180 days
Time Frame: 180 days after onset
180 days after onset
Proportion of participants with Barthel index 75-100 at 180 days
Time Frame: 180 days after onset
180 days after onset
Incidence of post-hemorrhagic hydrocephalus
Time Frame: Up to 180 days after onset
Up to 180 days after onset
Length of hospital stay
Time Frame: Perioperative period
Perioperative period
Total hospitalization cost
Time Frame: Perioperative period
Perioperative period

Other Outcome Measures

Outcome Measure
Time Frame
All-cause mortality at 90 days and 180 days
Time Frame: 90 days, 180 days after onset
90 days, 180 days after onset
Incidence of bacterial ventriculitis or meningitis
Time Frame: During treatment and 180-day follow-up
During treatment and 180-day follow-up
Incidence of cerebral hernia
Time Frame: Perioperative period
Perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Xingen Zhu, Prof, Second Affiliated Hospital of Nanchang University
  • Principal Investigator: Shigang Lv, MD, Second Affiliated Hospital of Nanchang University
  • Principal Investigator: Miaojing Wu, MD, Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LD-IVH-2026-001
  • ChiCTR2600123877 (Registry Identifier: Chinese Clinical Trial Registry (ChiCTR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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