Lumbar Drainage of Intraventricular Hemorrhage

Recruiting now · Not applicable

Conditions studied: Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage

In brief

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.

Key facts

Study ID

NCT06510842

Run by

University Hospital Heidelberg

People needed

354

Starts

2025-01-16

Expected to finish

2029-07-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Neurology, University Hospital Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• LMU München — München, Bavaria, Germany (enrolling)
• Augsburg University Hospital — Augsburg, Germany (enrolling)
• Augsburg University Hospital Department of Neurosurgery — Heidelberg, Germany (enrolling)
• Heidelberg University Hospital Department of Neurosurgery — Heidelberg, Germany (enrolling)
• Mannheim University Hospital — Mannheim, Germany (enrolling)
• Osnabrück Clinic — Osnabrück, Germany (enrolling)
• Düsseldorf Universitiy Hospital — Düsseldorf, Germany (enrolling)
• Charite Universitätsmedizin Berlin — Berlin, Germany
• Mainz University Hospital — Mainz, Germany
• Frankfurt University Hospital — Frankfurt, Germany
• Goettingen University Hospital — Göttingen, Germany

Full record on ClinicalTrials.gov

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