Early Lumbar Drainage for Intraventricular 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lumbar Drainage combined with external ventricular drainage plus Intrathecal Urokinase
Procedure/SurgeryEarly 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 Urokinase
Procedure/SurgeryPatients 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.
Treatment groups
392 Participants
are divided into 2 treatment groupsGroup A: Control Group (EVD + Intrathecal Urokinase)Active comparator 1 intervention
Group B: Intervention Group (EVD + Urokinase + Early Lumbar Cistern Drainage)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 onsetSecondary outcomes
1
Proportion of participants with mRS 0-3 at 90 days after onset
Time frame
90 days after onset2
Proportion of participants with GOS score 4-5 at 180 days after onset
Time frame
180 days after onset3
Proportion of participants with mRS 0-2 at 90 days and 180 days
Time frame
90 days, 180 days after onset4
Ordinal change of mRS score from baseline to 180 days
Time frame
Baseline to 180 daysOther outcomes
1
All-cause mortality at 90 days and 180 days
Time frame
90 days, 180 days after onset2
Incidence of bacterial ventriculitis or meningitis
Time frame
During treatment and 180-day follow-up3
Incidence of cerebral hernia
Time frame
Perioperative periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital of Nanchang University
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov
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