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Lumbar Drainage of Intraventricular Hemorrhage

RecruitingNAAges 18 Years - anyAllUniversity Hospital Heidelberg
NCT06510842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus * Age ≥ 18 y * Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well Exclusion Criteria: * Premorbid mRS score \> 2 * Pregnancy * Life expectancy \<6 months * Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures. * Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted. * Other clear contraindication for treatment with a lumbar drain
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What it tests

  • External drainage of intraventricular hemorrhage
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Where

12 sites
Department of Neurology, University Hospital Heidelberg
Heidelberg, Germany
LMU München
München, 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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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