Kuramatsu, Joji B. ORCID: 0000-0002-7630-7880, Gerner, Stefan T., Ziai, Wendy, Bardutzky, Juergen, Sembill, Jochen A. ORCID: 0000-0003-0014-3389, Spruegel, Maximilian, I, Mrochen, Anne, Koelbl, Kathrin, Ram, Malathi, Avadhani, Radhika, Falcone, Guido J., Selim, Magdy H., Lioutas, Vasileios-Arsenios, Endres, Matthias ORCID: 0000-0001-6520-3720, Zweynert, Sarah ORCID: 0000-0002-1665-2666, Vajkoczy, Peter, Ringleb, Peter A., Purrucker, Jan C., Volkmann, Jens, Neugebauer, Hermann, Erbguth, Frank, Schellinger, Peter D., Knappe, Ulrich J., Fink, Gereon R. ORCID: 0000-0002-8230-1856, Dohmen, Christian, Minnerup, Jens, Reichmann, Heinz, Schneider, Hauke ORCID: 0000-0002-9641-0922, Roether, Joachim, Reimann, Gernot, Schwarz, Michael, Baezner, Hansjoerg, Classen, Joseph, Michalski, Dominik, Witte, Otto W., Guenther, Albrecht, Hamann, Gerhard F., Luecking, Hannes, Doerfler, Arnd, Ishfaq, Muhammad Fawad, Chang, Jason J., Testai, Fernando D., Woo, Daniel, Alexandrov, Andrei, V, Staykov, Dimitre, Goyal, Nitin, Tsivgoulis, Georgios, Sheth, Kevin N., Awad, Issam A., Schwab, Stefan, Hanley, Daniel F. and Huttner, Hagen B. (2022). Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis. Stroke, 53 (9). S. 2876 - 2887. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1524-4628

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Abstract

Background: In patients with intracerebral hemorrhage (ICH), the presence of intraventricular hemorrhage constitutes a promising therapeutic target. Intraventricular fibrinolysis (IVF) reduces mortality, yet impact on functional disability remains unclear. Thus, we aimed to determine the influence of IVF on functional outcomes. Methods: This individual participant data meta-analysis pooled 1501 patients from 2 randomized trials and 7 observational studies enrolled during 2004 to 2015. We compared IVF versus standard of care (including placebo) in patients treated with external ventricular drainage due to acute hydrocephalus caused by ICH with intraventricular hemorrhage. The primary outcome was functional disability evaluated by the modified Rankin Scale (mRS; range: 0-6, lower scores indicating less disability) at 6 months, dichotomized into mRS score: 0 to 3 versus mRS: 4 to 6. Secondary outcomes included ordinal-shift analysis, all-cause mortality, and intracranial adverse events. Confounding and bias were adjusted by random effects and doubly robust models to calculate odds ratios and absolute treatment effects (ATE). Results: Comparing treatment of 596 with IVF to 905 with standard of care resulted in an ATE to achieve the primary outcome of 9.3% (95% CI, 4.4-14.1). IVF treatment showed a significant shift towards improved outcome across the entire range of mRS estimates, common odds ratio, 1.75 (95% CI, 1.39-2.17), reduced mortality, odds ratio, 0.47 (95% CI, 0.35-0.64), without increased adverse events, absolute difference, 1.0% (95% CI, -2.7 to 4.8). Exploratory analyses provided that early IVF treatment (<= 48 hours) after symptom onset was associated with an ATE, 15.2% (95% CI, 8.6-21.8) to achieve the primary outcome. Conclusions: As compared to standard of care, the administration of IVF in patients with acute hydrocephalus caused by intracerebral and intraventricular hemorrhage was significantly associated with improved functional outcome at 6 months. The treatment effect was linked to an early time window <48 hours, specifying a target population for future trials.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kuramatsu, Joji B.UNSPECIFIEDorcid.org/0000-0002-7630-7880UNSPECIFIED
Gerner, Stefan T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ziai, WendyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bardutzky, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sembill, Jochen A.UNSPECIFIEDorcid.org/0000-0003-0014-3389UNSPECIFIED
Spruegel, Maximilian, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mrochen, AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koelbl, KathrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ram, MalathiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Avadhani, RadhikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Falcone, Guido J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Selim, Magdy H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lioutas, Vasileios-ArseniosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Endres, MatthiasUNSPECIFIEDorcid.org/0000-0001-6520-3720UNSPECIFIED
Zweynert, SarahUNSPECIFIEDorcid.org/0000-0002-1665-2666UNSPECIFIED
Vajkoczy, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ringleb, Peter A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Purrucker, Jan C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volkmann, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neugebauer, HermannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Erbguth, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schellinger, Peter D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Knappe, Ulrich J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Gereon R.UNSPECIFIEDorcid.org/0000-0002-8230-1856UNSPECIFIED
Dohmen, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Minnerup, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reichmann, HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, HaukeUNSPECIFIEDorcid.org/0000-0002-9641-0922UNSPECIFIED
Roether, JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reimann, GernotUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwarz, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baezner, HansjoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Classen, JosephUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michalski, DominikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Witte, Otto W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guenther, AlbrechtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hamann, Gerhard F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luecking, HannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doerfler, ArndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ishfaq, Muhammad FawadUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chang, Jason J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Testai, Fernando D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woo, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alexandrov, Andrei, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staykov, DimitreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goyal, NitinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tsivgoulis, GeorgiosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sheth, Kevin N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Awad, Issam A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwab, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hanley, Daniel F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huttner, Hagen B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-698204
DOI: 10.1161/STROKEAHA.121.038455
Journal or Publication Title: Stroke
Volume: 53
Number: 9
Page Range: S. 2876 - 2887
Date: 2022
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1524-4628
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
TISSUE-PLASMINOGEN ACTIVATOR; PERIHEMATOMAL EDEMA; PRESSURE LEVELS; STROKE; GUIDELINES; MANAGEMENT; HEMATOMA; EXACERBATIONMultiple languages
Clinical Neurology; Peripheral Vascular DiseaseMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69820

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