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Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis.
Kuramatsu, Joji B; Gerner, Stefan T; Ziai, Wendy; Bardutzky, Jürgen; Sembill, Jochen A; Sprügel, Maximilian I; Mrochen, Anne; Kölbl, Kathrin; Ram, Malathi; Avadhani, Radhika; Falcone, Guido J; Selim, Magdy H; Lioutas, Vasileios-Arsenios; Endres, Matthias; Zweynert, Sarah; Vajkoczy, Peter; Ringleb, Peter A; Purrucker, Jan C; Volkmann, Jens; Neugebauer, Hermann; Erbguth, Frank; Schellinger, Peter D; Knappe, Ulrich J; Fink, Gereon R; Dohmen, Christian; Minnerup, Jens; Reichmann, Heinz; Schneider, Hauke; Röther, Joachim; Reimann, Gernot; Schwarz, Michael; Bäzner, Hansjörg; Claßen, Joseph; Michalski, Dominik; Witte, Otto W; Günther, Albrecht; Hamann, Gerhard F; Lücking, Hannes; Dörfler, 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.
Affiliation
  • Kuramatsu JB; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Gerner ST; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Ziai W; Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD (W.Z., M.R., R.A., D.F.H.).
  • Bardutzky J; Department of Neurology, University of Freiburg, Germany (J.B.).
  • Sembill JA; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Sprügel MI; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Mrochen A; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Kölbl K; Department of Neurology (J.B.K., S.T.G., J.A.S., M.I.S., A.M., K.K., D.S., S.S., H.B.H.), University of Erlangen-Nuremberg, Germany.
  • Ram M; Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD (W.Z., M.R., R.A., D.F.H.).
  • Avadhani R; Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD (W.Z., M.R., R.A., D.F.H.).
  • Falcone GJ; Department of Neurology (G.J.F.), Yale University School of Medicine, New Haven, CT.
  • Selim MH; Department of Neurosurgery (G.J.F., K.N.S.), Yale University School of Medicine, New Haven, CT.
  • Lioutas VA; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.H.S., V.A.L.).
  • Endres M; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.H.S., V.A.L.).
  • Zweynert S; Department of Neurology (M.E., S.Z.), Charité-Universitätsmedizin Berlin, Germany.
  • Vajkoczy P; Center for Stroke Research Berlin, Germany (M.E.).
  • Ringleb PA; German Centre for Cardiovascular Research (DZHK) (M.E.).
  • Purrucker JC; German Center for Neurodegenerative Diseases (DZNE) (M.E.).
  • Volkmann J; Department of Neurology (M.E., S.Z.), Charité-Universitätsmedizin Berlin, Germany.
  • Neugebauer H; Department of Neurosurgery (P.V.), Charité-Universitätsmedizin Berlin, Germany.
  • Erbguth F; Department of Neurology, Heidelberg University Hospital, Germany (P.A.R., J.C.P.).
  • Schellinger PD; Department of Neurology, Heidelberg University Hospital, Germany (P.A.R., J.C.P.).
  • Knappe UJ; Department of Neurology, University of Würzburg, Germany (J.V., H.N.).
  • Fink GR; Department of Neurology, University of Würzburg, Germany (J.V., H.N.).
  • Dohmen C; Department of Neurology, University of Ulm, Germany (H.N.).
  • Minnerup J; Department of Neurology, Nuremberg General Hospital, Germany (F.E.).
  • Reichmann H; Department of Neurology and Neurogeriatry (P.D.S.), Johannes Wesling Medical Center Minden, Germany.
  • Schneider H; Department of Neurosurgery (U.J.K.), Johannes Wesling Medical Center Minden, Germany.
  • Röther J; Department of Neurology, University of Cologne, Germany (G.R.F., C.D.).
  • Reimann G; Department of Neurology, University of Cologne, Germany (G.R.F., C.D.).
  • Schwarz M; Department of Neurology, LVR-Hospital Bonn, Germany (C.D.).
  • Bäzner H; Department of Neurology, University of Münster, Germany (J.M.).
  • Claßen J; Department of Neurology, University of Dresden, Germany (H.R., H.S.).
  • Michalski D; Department of Neurology, University of Dresden, Germany (H.R., H.S.).
  • Witte OW; Department of Neurology, Klinikum Augsburg, Germany (H.S.).
  • Günther A; Department of Neurology, Asklepios Klinikum Hamburg Altona, Germany (J.R.).
  • Hamann GF; Department of Neurology, Klinikum Dortmund, Germany (G.R., M.S.).
  • Lücking H; Department of Neurology, Klinikum Dortmund, Germany (G.R., M.S.).
  • Dörfler A; Department of Neurology, Klinikum Stuttgart, Germany (H.B.).
  • Ishfaq MF; Department of Neurology, University of Leipzig, Germany (J.C., D.M.).
  • Chang JJ; Department of Neurology, University of Leipzig, Germany (J.C., D.M.).
  • Testai FD; Department of Neurology, University of Jena, Germany (O.W.W., A.G.).
  • Woo D; Department of Neurology, University of Jena, Germany (O.W.W., A.G.).
  • Alexandrov AV; Department of Neurology and Neurological Rehabilitation, Bezirkskrankenhaus Günzburg, Germany (G.F.H.).
  • Staykov D; Department of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Germany.
  • Goyal N; Department of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Germany.
  • Tsivgoulis G; Department of Neurology, University of Tennessee Health Science Center, Memphis (M.F.I., A.V.A., N.G., G.T.).
  • Sheth KN; Department of Critical Care Medicine, MedStar Washington Hospital Center, Washington, DC (J.J.C.).
  • Awad IA; Department of Neurology and Rehabilitation, University of Illinois College of Medicine, Chicago (F.D.T.).
  • Schwab S; Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH (D.W.).
Stroke ; 53(9): 2876-2886, 2022 09.
Article in En | MEDLINE | ID: mdl-35521958
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Fibrinolysis / Hydrocephalus Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limits: Humans Language: En Journal: Stroke Year: 2022 Document type: Article Affiliation country: Germany
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Fibrinolysis / Hydrocephalus Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limits: Humans Language: En Journal: Stroke Year: 2022 Document type: Article Affiliation country: Germany