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Lumbar Drainage of Intraventricular Hemorrhage
Sponsor: University Hospital Heidelberg
Summary
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.
Official title: Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
354
Start Date
2025-01-16
Completion Date
2029-07
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
External drainage of intraventricular hemorrhage
An EVD is required to be eligible for the DRAIN IVH study. Weaning from the EVD is at the discretion of the local investigators. Imaging is at discretion of local investigators. Use, timing and frequency of fibrinolysis via EVD is at local discretion, too.
Locations (12)
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
LMU München
München, Bavaria, Germany
Augsburg University Hospital
Augsburg, Germany
Charite Universitätsmedizin Berlin
Berlin, Germany
Düsseldorf Universitiy Hospital
Düsseldorf, Germany
Frankfurt University Hospital
Frankfurt, Germany
Goettingen University Hospital
Göttingen, Germany
Augsburg University Hospital Department of Neurosurgery
Heidelberg, Germany
Heidelberg University Hospital Department of Neurosurgery
Heidelberg, Germany
Mainz University Hospital
Mainz, Germany
Mannheim University Hospital
Mannheim, Germany
Osnabrück Clinic
Osnabrück, Germany