An interventional study of Control treatment plus lumbar drainage and Control treatment schedule in Intraventricular Hemorrhage and Cerebral Hemorrhage, sponsored by Second Affiliated Hospital of Nanchang University. Not yet recruiting at 31 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Patients received external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase was administered as a single daily dose of 30,000 IU for 3 consecutive days. A follow-up cranial CT was then performed to assess ventricular obstruction and hematoma clearance, which guided the decision on whether to continue thrombolysis. The maximum total duration of urokinase treatment did not exceed 5 days. Thrombolysis was discontinued when CT demonstrated clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
Procedure: Control treatment schedule
In addition to the same EVD and intrathecal urokinase regimen as the control group, early lumbar 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.
Procedure: Control 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.
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%.
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
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.
Time frame: 180 days after disease onset
Proportion of participants with shunt-dependent hydrocephalus before discharge and at 180 days after onset
Percentage of patients requiring permanent cerebrospinal fluid shunting for hydrocephalus before hospital discharge and at the 180-day follow-up.
Time frame: Before hospital discharge and 180 days after disease onset
Daily CSF drainage volume 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.
Time frame: During the drainage period before catheter removal
Proportion of participants with resolution of third and/or fourth ventricular obstruction
Percentage of patients with resolution of third and/or fourth ventricular obstruction on cranial CT within 14 days after enrollment or before hospital discharge.
Time frame: Within 14 days after enrollment or before hospital discharge
Dynamic intracranial hemorrhage clearance rate before catheter removal
Serial (dynamic) rate of intracranial hemorrhage clearance on cranial CT before removal of the external ventricular and lumbar drainage catheters.
Time frame: Before removal of the external ventricular and lumbar drainage catheters
Length of hospital stay
Total duration of hospitalization (days).
Time frame: From admission to hospital discharge
Length of NICU stay
Total duration of stay in the intensive care unit (days).
Time frame: From NICU admission to NICU discharge
Total hospitalization costs
Total medical costs incurred during hospitalization, in RMB.
Time frame: From admission to hospital discharge
All-cause mortality at 180 days after onset
Percentage of patients who died from any cause by the 180-day follow-up.
Time frame: 180 days after disease onset
Proportion of participants with intracranial infection
Percentage of patients who developed intracranial infection during the study period.
Time frame: From enrollment through hospital discharge
Proportion of participants with cerebral herniation
Percentage of patients who developed cerebral herniation.
Time frame: From enrollment through hospital discharge
Proportion of participants with symptomatic rebleeding within 72 hours after catheter placement or thrombolysis
Percentage of patients with symptomatic intracranial rebleeding within 72 hours after catheter placement or intrathecal thrombolysis.
Time frame: Within 72 hours after catheter placement or thrombolysis
Proportion of participants with other serious adverse events
Percentage of patients who experienced other serious adverse events during the study period.
Time frame: From enrollment through the 180-day follow-up
Plan to share: No
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Second Affiliated Hospital of Nanchang University