Early Lumbar Drainage for Intraventricular Hemorrhage

ConditionsIntraventricular Hemorrhage Cerebral Hemorrhage

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-85 years, of either sex.

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.

Intraparenchymal hemorrhage volume <30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization.

Randomization completed within 72 hours of symptom onset.

Disqualifiers

Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor.

Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase.

Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal.

Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site).

Trial design

Design model

Parallel

Treatments tested in this trial

Control treatment plus lumbar drainage
Procedure/Surgery
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 schedule
Procedure/Surgery
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%.

Treatment groups

392 Participants

are divided into 2 treatment groups

Group A: Control Group (EVD + Intrathecal Urokinase)Active comparator 1 intervention

Group B: Intervention Group (Control Treatment + Lumbar Drainage)Experimental treatment 1 intervention

Trial 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

Other outcomes

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

Locations31

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Sponsors and contacts

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Second Affiliated Hospital of Nanchang University

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

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