Early Lumbar Drainage for Intraventricular Hemorrhage

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07625449

Acronym

LD-IVH

Enrollment

392

Registered

2026-06-04

Start date

2026-10-01

Completion date

2029-10-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage, Intraventricular Hemorrhage

Keywords

Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage, Urokinase, PROBE design, Randomized Controlled Trial

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.

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 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.

Interventions

PROCEDUREControl treatment plus lumbar drainage

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.

PROCEDUREControl treatment schedule

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%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
EQ-5D score at 180 days after onset	180 days after disease onset	Health-related quality of life measured by the EuroQol-5D (EQ-5D) questionnaire at the 180-day follow-up.
Proportion of participants with Barthel Index score 75-100 at 180 days after onset	180 days after disease onset	Percentage of patients with a Barthel Index score of 75 to 100 at the 180-day follow-up.
Proportion of participants with shunt-dependent hydrocephalus before discharge and at 180 days after onset	Before hospital discharge and 180 days after disease onset	Percentage of patients requiring permanent cerebrospinal fluid shunting for hydrocephalus before hospital discharge and at the 180-day follow-up.
Daily CSF drainage volume before catheter removal	During the drainage period before catheter removal	Daily volume of cerebrospinal fluid drained (mL/day) from the external ventricular drain and lumbar drain before removal of the drainage catheters.
Proportion of participants with resolution of third and/or fourth ventricular obstruction	Within 14 days after enrollment or before hospital discharge	Percentage of patients with resolution of third and/or fourth ventricular obstruction on cranial CT within 14 days after enrollment or before hospital discharge.
Dynamic intracranial hemorrhage clearance rate before catheter removal	Before removal of the external ventricular and lumbar drainage catheters	Serial (dynamic) rate of intracranial hemorrhage clearance on cranial CT before removal of the external ventricular and lumbar drainage catheters.
Length of hospital stay	From admission to hospital discharge	Total duration of hospitalization (days).
Length of NICU stay	From NICU admission to NICU discharge	Total duration of stay in the intensive care unit (days).
Total hospitalization costs	From admission to hospital discharge	Total medical costs incurred during hospitalization, in RMB.
Proportion of participants with mRS 0-2 at 90 days and 180 days	90 and 180 days after disease onset	Percentage of patients with a modified Rankin Scale score of 0 to 2 at the 90- and 180-day follow-up.
Proportion of participants with GOS score 4-5 at 180 days after onset	180 days after onset	Percentage of patients with a Glasgow Outcome Scale (GOS) score of 4 or 5 at the 180-day follow-up.
Change in ordinal mRS score from baseline to 180 days after onset	Baseline to 180 days after disease onset	Change in the ordinal modified Rankin Scale score between baseline and the 180-day follow-up.
Proportion of participants with mRS 0-3 at 90 days after onset	90 days after onset	Percentage of patients with a modified Rankin Scale score of 0 to 3 at the 90-day follow-up.

Countries

China

Contacts

CONTACTPing Hu, MD

hp666edu@163.com+86 13097286794

PRINCIPAL_INVESTIGATORShigang Lv, MD

Second Affiliated Hospital of Nanchang University

PRINCIPAL_INVESTIGATORMiaojing Wu, MD