Using lumbar drainage to treat intraventricular hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of early lumbar drainage in patients with intraventricular hemorrhage (IVH) who require external ventricular drainage (EVD) due to acute hydrocephalus. The study hypothesizes that adding lumbar drainage will improve functional outcomes and reduce the need for permanent ventriculoperitoneal shunts by facilitating the removal of blood that causes inflammation in the subarachnoid space. It is a multi-center randomized trial conducted at several prominent medical institutions in Germany.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
* Other clear contraindication for treatment with a lumbar drain

Where it's running

• Department of Neurology, University Hospital Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• LMU München
  München, Bavaria, Germany Recruiting
• Augsburg University Hospital
  Augsburg, Germany Recruiting
• Düsseldorf Universitiy Hospital
  Düsseldorf, Germany Recruiting
• Augsburg University Hospital Department of Neurosurgery
  Heidelberg, Germany Recruiting
• Heidelberg University Hospital Department of Neurosurgery
  Heidelberg, Germany Recruiting

Study contacts

• Principal investigator: Silvia Schönenberger, MD — Heidelberg University Hospital, Department of Neurology
• Study coordinator: Silvia Schönenberger, MD
• Email: silvia.schoenenberger@med.uni-heidelberg.de
• Phone: 0049/6221/567504

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.