Lumbar Drainage of Intraventricular Hemorrhage the DRAIN IVH Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charite Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Department of Neurology, University Hospital Heidelberg
RECRUITING
Heidelberg
LMU München
RECRUITING
München
Contact Information
Primary
Silvia Schönenberger, MD
silvia.schoenenberger@med.uni-heidelberg.de
0049/6221/567504
Backup
Min Chen, MD
min.chen@med.uni-heidelberg.de
0049/6221/567504
Time Frame
Start Date: 2025-01-16
Estimated Completion Date: 2029-07
Participants
Target number of participants: 354
Treatments
Experimental: Intervention arm
Additional insertion of a lumbar drainage.
Active_comparator: Control arm
Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov