Using lumbar drainage to treat intraventricular hemorrhage

Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial

This study is testing if using lumbar drainage early on can help patients with intraventricular hemorrhage recover better and reduce the need for permanent shunts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 354 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Heidelberg (Academic / other)
• Locations: 12 sites (Heidelberg, Baden-Wurttemberg and 11 other locations)
• Trial ID: NCT06510842 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with intracerebral hemorrhage and intraventricular hemorrhage requiring EVD placement within 72 hours of symptom onset.

Not a fit: Patients with a poor premorbid mRS score, those who are pregnant, or individuals with a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery and reduced long-term complications for patients suffering from intraventricular hemorrhage.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.

Eligibility criteria

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 this trial is running

Heidelberg, Baden-Wurttemberg and 11 other locations

• Department of Neurology, University Hospital Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
• LMU München — München, Bavaria, Germany (Recruiting)
• Augsburg University Hospital — Augsburg, Germany (Recruiting)
• Charite Universitätsmedizin Berlin — Berlin, Germany (Not_yet_recruiting)
• Düsseldorf Universitiy Hospital — Düsseldorf, Germany (Recruiting)
• Frankfurt University Hospital — Frankfurt, Germany (Not_yet_recruiting)
• Goettingen University Hospital — Göttingen, Germany (Not_yet_recruiting)
• Augsburg University Hospital Department of Neurosurgery — Heidelberg, Germany (Recruiting)
• Heidelberg University Hospital Department of Neurosurgery — Heidelberg, Germany (Recruiting)
• Mainz University Hospital — Mainz, Germany (Not_yet_recruiting)
• Mannheim University Hospital — Mannheim, Germany (Recruiting)
• Osnabrück Clinic — Osnabrück, Germany (Recruiting)

Study contacts

• Principal investigator: Silvia Schönenberger, MD — Heidelberg University Hospital, Department of Neurology
• Study coordinator: Silvia Schönenberger, MD

Conditions Intraventricular Hemorrhage; Lumbar Drainage; External Ventricular Drainage