Lumbar Drainage of Intraventricular Hemorrhage

Last updated: January 16, 2025
Sponsor: University Hospital Heidelberg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Brain Injury

Hemorrhage

Treatment

External drainage of intraventricular hemorrhage

Clinical Study ID

NCT06510842
S-304/2024
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need forEVD placement due to acute hydrocephalus

  • Age ≥ 18 y

  • Lumbar drain can be inserted within 72 h after symptom onset or patient last seenwell

Exclusion

Exclusion Criteria:

  • Premorbid mRS score > 2

  • Pregnancy

  • Life expectancy <6 months

  • Patient/family/caregiver unwilling or unlikely to opt for at least two weeks ofaggressive therapy prior to consideration of transition to comfortmeasures/discontinuation of life support measures.

  • Treating physicians deeming the prognosis as so grave that an aggressive therapy isnot warranted.

  • Other clear contraindication for treatment with a lumbar drain

Study Design

Total Participants: 354
Treatment Group(s): 1
Primary Treatment: External drainage of intraventricular hemorrhage
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Department of Neurology, University Hospital Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Active - Recruiting

  • LMU München

    München, Bayern
    Germany

    Active - Recruiting

  • Charite Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

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