Early Lumbar Drainage for Intraventricular Hemorrhage

N/ANot Yet RecruitingNCT07625449

Second Affiliated Hospital of Nanchang University392 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Intraventricular Hemorrhage Cerebral Hemorrhage

Interventions

Lumbar Drainage combined with external ventricular drainage plus Intrathecal UrokinasePROCEDURE

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.

External ventricular drainage plus Intrathecal UrokinasePROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Locations (29)

Outcomes

Primary Outcomes

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.

Time frame: 180 days after disease onset

Secondary Outcomes

Proportion of participants with mRS 0-3 at 90 days after onset

Time frame: 90 days after onset

Proportion of participants with GOS score 4-5 at 180 days after onset

Time frame: 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

Ordinal change of mRS score from baseline to 180 days

Time frame: Baseline to 180 days

EQ-5D health utility score at 180 days

Time frame: 180 days after onset

Proportion of participants with Barthel index 75-100 at 180 days

Time frame: 180 days after onset

Incidence of post-hemorrhagic hydrocephalus

Time frame: Up to 180 days after onset

Length of hospital stay

Time frame: Perioperative period

Total hospitalization cost

Time frame: Perioperative period

Central Contacts

Ping Hu, MD

CONTACT

+86 13097286794 hp666edu@163.com

Data from ClinicalTrials.gov

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