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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
354
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.
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGLMU München
München, Bavaria, Germany
RECRUITINGAugsburg University Hospital
Augsburg, Germany
RECRUITINGCharite Universitätsmedizin Berlin
Berlin, Germany
NOT_YET_RECRUITINGDüsseldorf Universitiy Hospital
Düsseldorf, Germany
RECRUITINGFrankfurt University Hospital
Frankfurt, Germany
NOT_YET_RECRUITINGGoettingen University Hospital
Göttingen, Germany
NOT_YET_RECRUITINGAugsburg University Hospital Department of Neurosurgery
Heidelberg, Germany
RECRUITINGHeidelberg University Hospital Department of Neurosurgery
Heidelberg, Germany
RECRUITINGMainz University Hospital
Mainz, Germany
NOT_YET_RECRUITING...and 2 more locations
Rate of mRS
The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies.
Time frame: 180 days (+/- 14 days)
Amount of CSF drained by external ventricular drain
in ml
Time frame: up to 14 days (duration of hospital stay)
Amount of CSF drained by lumbar drain
in ml
Time frame: up to 14 days (duration of hospital stay)
Need for VP shunt
operative implantation of VP shunt
Time frame: up to 14 days (duration of hospital stay)
Need for VP shunt
operative implantation of VP shunt
Time frame: at 180 days
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Opening of third ventricle (y/n)
Time frame: up to 14 days (duration of hospital stay)
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Opening of fourth ventricle (y/n)
Time frame: up to 14 days (duration of hospital stay)
Bacterial Ventriculitis/Meningitis leading to antibiotic treatment
(y/n)
Time frame: up to 14 days (duration of hospital stay)
Mortality
cerebral cause of death (y/n)
Time frame: up to 14 days (duration of hospital stay) and 6 month
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