Lumbar Drainage of Intraventricular Hemorrhage
Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
University Hospital Heidelberg
354 participants
Jan 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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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Interventions
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)
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NCT06510842