Lumbar Drainage of Intraventricular Hemorrhage (DRAIN IVH)

Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intraventricular Hemorrhage; Lumbar Drainage; External Ventricular Drainage
• Intervention / Treatment: Other: External drainage of intraventricular hemorrhage

• Study Type: Interventional
• Enrollment (Estimated): 354
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Schönenberger, MD; Phone Number: 0049/6221/567504; Email: silvia.schoenenberger@med.uni-heidelberg.de
• Study Contact Backup: Name: Min Chen, MD; Phone Number: 0049/6221/567504; Email: min.chen@med.uni-heidelberg.de

Study Locations

• Germany
  • Augsburg, Germany
    • Recruiting
    • Augsburg University Hospital
    • Contact: Hauke Schneider, PD Dr.; Phone Number: 0049/821/400-01; Email: hauke.schneider@uk-augsburg.de
  • Berlin, Germany
    • Not yet recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Stefan Wolf, Dr.
  • Düsseldorf, Germany
    • Recruiting
    • Düsseldorf Universitiy Hospital
    • Contact: Kerim Beseoglu, Prof. Dr.; Phone Number: +49 (0) 2 11-81 00; Email: Kerim.Beseoglu@med.uni-duesseldorf.de
  • Frankfurt, Germany
    • Not yet recruiting
    • Frankfurt University Hospital
    • Contact: Marcus Czabanka, Prof. Dr.; Phone Number: 049/69 63010; Email: Czabanka@med.uni-frankfurt.de
  • Göttingen, Germany
    • Not yet recruiting
    • Goettingen University Hospital
    • Contact: Tammam Abboud, PD Dr.; Phone Number: 049/551/390; Email: Tammam.abboud@med.uni-goettingen.de
  • Heidelberg, Germany
    • Recruiting
    • Augsburg University Hospital Department of Neurosurgery
    • Contact: Nadine Lilla, PD Dr.; Phone Number: 0049/821 400-01; Email: Nadine.Lilla@uk-augsburg.de
  • Heidelberg, Germany
    • Recruiting
    • Heidelberg University Hospital Department of Neurosurgery
    • Contact: Martin Jakobs, Prof. Dr.; Phone Number: 0049/6221/560; Email: martin.jakobs@med.uni-heidelberg.de
  • Mainz, Germany
    • Not yet recruiting
    • Mainz University Hospital
    • Contact: Thomas Kerz, Dr.; Phone Number: +49 6131 39-0; Email: kerz@uni-mainz.de
  • Mannheim, Germany
    • Recruiting
    • Mannheim University Hospital
    • Contact: Christopher Beynon, Prof. Dr.; Phone Number: 0049/621/383-0; Email: christopher.beynon@umm.de
  • Osnabrück, Germany
    • Recruiting
    • Osnabrück Clinic
    • Contact: Volker Schulte, Dr.; Phone Number: 049/541/4050; Email: Volker.Schulte@klinikum-os.de
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Recruiting
      • Department of Neurology, University Hospital Heidelberg
      • Contact: Silvia Schönenberger, Dr.; Phone Number: 0049-6221-5637549; Email: silvia.schoenenberger@med.uni-heidelberg.de
      • Sub-Investigator: Silvia Schönenberger, Dr.
  • Bavaria
    • München, Bavaria, Germany
      • Recruiting
      • LMU München
      • Contact: Konstantinos Dimitriadis, Prof. Dr.; Phone Number: 004989440073690; Email: Konstantin.Dimitriadis@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Additional insertion of a lumbar drainage.	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.
Active Comparator: Control arm; Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mRS	The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies.	180 days (+/- 14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of CSF drained by external ventricular drain	in ml	up to 14 days (duration of hospital stay)
Amount of CSF drained by lumbar drain	in ml	up to 14 days (duration of hospital stay)
Need for VP shunt	operative implantation of VP shunt	up to 14 days (duration of hospital stay)
Need for VP shunt	operative implantation of VP shunt	at 180 days
Clearance of intraventricular blood (via neuroimaging with CT or MRI)	Opening of third ventricle (y/n)	up to 14 days (duration of hospital stay)
Clearance of intraventricular blood (via neuroimaging with CT or MRI)	Opening of fourth ventricle (y/n)	up to 14 days (duration of hospital stay)
Bacterial Ventriculitis/Meningitis leading to antibiotic treatment	(y/n)	up to 14 days (duration of hospital stay)
Mortality	cerebral cause of death (y/n)	up to 14 days (duration of hospital stay) and 6 month

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Silvia Schönenberger, MD, Heidelberg University Hospital, Department of Neurology

Publications and helpful links

General Publications

• Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.
• Staykov D, Huttner HB, Struffert T, Ganslandt O, Doerfler A, Schwab S, Bardutzky J. Intraventricular fibrinolysis and lumbar drainage for ventricular hemorrhage. Stroke. 2009 Oct;40(10):3275-80. doi: 10.1161/STROKEAHA.109.551945. Epub 2009 Aug 13.
• Kuramatsu JB, Gerner ST, Ziai W, Bardutzky J, Sembill JA, Sprugel MI, Mrochen A, Kolbl K, Ram M, Avadhani R, Falcone GJ, Selim MH, Lioutas VA, Endres M, Zweynert S, Vajkoczy P, Ringleb PA, Purrucker JC, Volkmann J, Neugebauer H, Erbguth F, Schellinger PD, Knappe UJ, Fink GR, Dohmen C, Minnerup J, Reichmann H, Schneider H, Rother J, Reimann G, Schwarz M, Bazner H, Classen J, Michalski D, Witte OW, Gunther A, Hamann GF, Lucking H, Dorfler A, Ishfaq MF, Chang JJ, Testai FD, Woo D, Alexandrov AV, Staykov D, Goyal N, Tsivgoulis G, Sheth KN, Awad IA, Schwab S, Hanley DF, Huttner HB; Collaborators. Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis. Stroke. 2022 Sep;53(9):2876-2886. doi: 10.1161/STROKEAHA.121.038455. Epub 2022 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: DRAIN IVH; S-304/2024 (Other Identifier: Medizinische Ethikkomission Heidelberg)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No