Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06510842

Lumbar Drainage of Intraventricular Hemorrhage

Led by University Hospital Heidelberg · Updated on 2026-01-28

354

Participants Needed

12

Research Sites

232 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Lumbar Drainage of Intraventricular Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Intracerebral hemorrhage with intraventricular hemorrhage in the 3rd and/or 4th ventricle requiring external ventricular drain placement due to acute hydrocephalus
  • Age 18 years or older
  • Lumbar drain can be inserted within 72 hours after symptom onset or last seen well
Not Eligible

You will not qualify if you...

  • Premorbid Modified Rankin Scale score greater than 2
  • Pregnancy
  • Life expectancy less than 6 months
  • Patient, family, or caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy before comfort measures
  • Treating physicians consider prognosis too poor for aggressive therapy
  • Other clear contraindications for lumbar drain treatment

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

2

LMU München

München, Bavaria, Germany

Actively Recruiting

3

Augsburg University Hospital

Augsburg, Germany

Actively Recruiting

4

Charite Universitätsmedizin Berlin

Berlin, Germany

Not Yet Recruiting

5

Düsseldorf Universitiy Hospital

Düsseldorf, Germany

Actively Recruiting

6

Frankfurt University Hospital

Frankfurt, Germany

Not Yet Recruiting

7

Goettingen University Hospital

Göttingen, Germany

Not Yet Recruiting

8

Augsburg University Hospital Department of Neurosurgery

Heidelberg, Germany

Actively Recruiting

9

Heidelberg University Hospital Department of Neurosurgery

Heidelberg, Germany

Actively Recruiting

10

Mainz University Hospital

Mainz, Germany

Not Yet Recruiting

11

Mannheim University Hospital

Mannheim, Germany

Actively Recruiting

12

Osnabrück Clinic

Osnabrück, Germany

Actively Recruiting

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Research Team

S

Silvia Schönenberger, MD

CONTACT

M

Min Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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