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Lumbar Drainage of Intraventricular Hemorrhage

NCT06510842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2026-01-28

No results posted yet for this 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.

Conditions

  • Intraventricular Hemorrhage
  • Lumbar Drainage
  • External Ventricular Drainage

Interventions

OTHER

External drainage of intraventricular hemorrhage

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.

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Silvia Schönenberger, MD · Heidelberg University Hospital, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2029-01-31
Completion
2029-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510842 on ClinicalTrials.gov