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ClinicalTrials.gov ID

NCT07625449

Lead Sponsor

Second Affiliated Hospital of Nanchang UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

392Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Oct 2029Estimated

Completion Date

Oct 2029Estimated

Official Title

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

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.

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.

• Intraventricular Hemorrhage
• Cerebral Hemorrhage

• Lumbar Drainage combined with external ventricular drainage plus Intrathecal Urokinase
• External ventricular drainage plus Intrathecal Urokinase

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Second Affiliated Hospital of Nanchang UniversityOTHER

Collaborators

Shanghai Jiao Tong University School of MedicineOTHER

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