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
Qualifiers
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
Treatments tested in this trial
- Lumbar Drainage combined with external ventricular drainage plus Intrathecal Urokinase
- External ventricular drainage plus Intrathecal Urokinase
Treatment groups
392 Participants
are divided into 2 treatment groupsSponsors and collaborators
Second Affiliated Hospital of Nanchang University
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov