Lumbar Drainage of Intraventricular Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • External drainage of intraventricular hemorrhage

Treatment groups

354 Participants
are divided into 2 treatment groups

Sponsors and collaborators