Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
354 participants
INTERVENTIONAL
2025-01-16
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endoscopic Intraventricular Hematoma Evacuation Surgery Versus EVD for IVH
NCT04037267
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
NCT01041950
Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
NCT01064011
Cerebrospinal Fluid (CSF) Drainage Study
NCT01420978
Longitudinal Cohort Study on ICH Care
NCT03183167
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention arm
Additional insertion of a lumbar drainage.
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.
Control arm
Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 y
* Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Heidelberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Silvia Schönenberger, MD
Prof. Dr. Silvia Schönenberger
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Silvia Schönenberger, MD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University Hospital, Department of Neurology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
LMU München
München, Bavaria, Germany
Augsburg University Hospital
Augsburg, , Germany
Charite Universitätsmedizin Berlin
Berlin, , Germany
Düsseldorf Universitiy Hospital
Düsseldorf, , Germany
Frankfurt University Hospital
Frankfurt, , Germany
Goettingen University Hospital
Göttingen, , Germany
Augsburg University Hospital Department of Neurosurgery
Heidelberg, , Germany
Heidelberg University Hospital Department of Neurosurgery
Heidelberg, , Germany
Mainz University Hospital
Mainz, , Germany
Mannheim University Hospital
Mannheim, , Germany
Osnabrück Clinic
Osnabrück, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stefan Wolf, Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-304/2024
Identifier Type: OTHER
Identifier Source: secondary_id
DRAIN IVH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.