Lumbar Drainage of Intraventricular Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: External drainage of intraventricular hemorrhage.
- Who it may be relevant to
- Registry conditions: Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Rate of mRS [Time frame: 180 days (+/- 14 days)]
Secondary outcome measures (8)
- Amount of CSF drained by external ventricular drain [Time frame: up to 14 days (duration of hospital stay)]
- Amount of CSF drained by lumbar drain [Time frame: up to 14 days (duration of hospital stay)]
- Need for VP shunt [Time frame: up to 14 days (duration of hospital stay)]
- Need for VP shunt [Time frame: at 180 days]
- Clearance of intraventricular blood (via neuroimaging with CT or MRI) [Time frame: up to 14 days (duration of hospital stay)]
- Clearance of intraventricular blood (via neuroimaging with CT or MRI) [Time frame: up to 14 days (duration of hospital stay)]
- Bacterial Ventriculitis/Meningitis leading to antibiotic treatment [Time frame: up to 14 days (duration of hospital stay)]
- Mortality [Time frame: up to 14 days (duration of hospital stay) and 6 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 12 centers
- Department of Neurology, University Hospital Heidelberg — Heidelberg
- LMU München — München
- Augsburg University Hospital — Augsburg
- Charite Universitätsmedizin Berlin — Berlin
- Düsseldorf Universitiy Hospital — Düsseldorf
- Frankfurt University Hospital — Frankfurt
- Goettingen University Hospital — Göttingen
- Augsburg University Hospital Department of Neurosurgery — Heidelberg
- … and 4 more centers
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. do PMID 27888608
- 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. PMID 19679848
- 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, PMID 35521958
- Chen M, Sauer LD, Herweh C, Sander A, Klose C, Wick W, Wolf S, Schonenberger S. Lumbar drainage in intracerebral haemorrhage with intraventricular haemorrhage (DRAIN IVH): protocol for a multi-centre, randomised-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2026 May 4;11(5):aakag046. doi: 10.1093/esj/aakag046. PMID 42132469
Identifiers
NCT: NCT06510842 · DRAIN IVH · S-304/2024