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 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.

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 the 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. The LD-IVH study will use a 1:1 stratified block randomization design, with stratification by intraparenchymal hematoma and hospital. Eligible patients will be randomized to receive either (1) control group treatment: standard EVD plus daily intrathecal urokinase (30,000 IU) for 3 consecutive days, with a maximum treatment duration of 5 days; or (2) intervention group treatment: the same EVD and intrathecal urokinase regimen as the control group, with early lumbar drainage additionally initiated within 72 hours of onset. CSF was drained at a rate of ≤8 mL/h, with a daily maximum volume of 200 mL, to keep intracranial pressure stable. The primary endpoint will be the proportion of patients with a favorable functional outcome (modified Rankin Scale \[mRS\] score 0-3) at 180 days. A total of 392 patients will be enrolled, and an interim efficacy analysis is planned after 50% of participants complete the 180-day follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraventricular Hemorrhage Cerebral Hemorrhage

Interventions

Control treatment plus lumbar drainagePROCEDURE

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.

Control treatment schedulePROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18-85 years, of either sex. 2. 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. 3. Intraparenchymal hemorrhage volume \<30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization. 4. Randomization completed within 72 hours of symptom onset. 5. Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities). 6. Written informed consent obtained from the participant or a legal guardian. Exclusion Criteria: 1. Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor. 2. Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase. 3. Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal. 4. Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site). 5. Infratentorial hemorrhage with a volume ≥10 mL. 6. 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. 7. Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization. 8. Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts. 9. Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency. 10. Expected survival of less than 6 months due to other causes. 11. Other coexisting severe diseases that are difficult to treat. 12. Pregnancy. 13. Participation in another interventional clinical trial within 30 days before randomization. 14. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Locations (31)

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

Percentage of patients with a modified Rankin Scale score of 0 to 3 at the 90-day follow-up.

Time frame: 90 days after onset

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

Percentage of patients with a Glasgow Outcome Scale (GOS) score of 4 or 5 at the 180-day follow-up.

Time frame: 180 days after onset

Proportion of participants with mRS 0-2 at 90 days and 180 days

Percentage of patients with a modified Rankin Scale score of 0 to 2 at the 90- and 180-day follow-up.

Time frame: 90 and 180 days after disease onset

Change in ordinal mRS score from baseline to 180 days after onset

Change in the ordinal modified Rankin Scale score between baseline and the 180-day follow-up.

Time frame: Baseline to 180 days after disease onset

EQ-5D score at 180 days after onset

Health-related quality of life measured by the EuroQol-5D (EQ-5D) questionnaire at the 180-day follow-up.

Time frame: 180 days after disease onset

Proportion of participants with Barthel Index score 75-100 at 180 days after onset

Percentage of patients with a Barthel Index score of 75 to 100 at the 180-day follow-up.

Central Contacts

Ping Hu, MD

CONTACT

+86 13097286794 hp666edu@163.com

Data from ClinicalTrials.gov

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