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| ID | Type | Description | Link |
|---|---|---|---|
| S-304/2024 | Other Identifier | Medizinische Ethikkomission Heidelberg |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Additional insertion of a lumbar drainage. |
|
| Control arm | Active Comparator | Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External drainage of intraventricular hemorrhage | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Schönenberger, MD | Contact | 0049/6221/567504 | silvia.schoenenberger@med.uni-heidelberg.de | |
| Min Chen, MD | Contact | 0049/6221/567504 | min.chen@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Schönenberger, MD | Heidelberg University Hospital, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University Hospital Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27888608 | Background | 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. | |
| 19679848 |
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|
| 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 |
| LMU München | Recruiting | München | Bavaria | Germany |
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| Augsburg University Hospital | Recruiting | Augsburg | Germany |
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| Charite Universitätsmedizin Berlin | Not yet recruiting | Berlin | Germany |
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| Düsseldorf Universitiy Hospital | Recruiting | Düsseldorf | Germany |
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| Frankfurt University Hospital | Not yet recruiting | Frankfurt | Germany |
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| Goettingen University Hospital | Not yet recruiting | Göttingen | Germany |
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| Augsburg University Hospital Department of Neurosurgery | Recruiting | Heidelberg | Germany |
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| Heidelberg University Hospital Department of Neurosurgery | Recruiting | Heidelberg | Germany |
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| Mainz University Hospital | Not yet recruiting | Mainz | Germany |
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| Mannheim University Hospital | Recruiting | Mannheim | Germany |
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| Osnabrück Clinic | Recruiting | Osnabrück | Germany |
|
| Background |
| 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. |
| 35521958 | Background | 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. |
| 42132469 | Derived | 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. |