N Rahe-Meyer1, J H Levy2, C D Mazer3, A Schramko4, A A Klein5, R Brat6, Y Okita7, Y Ueda8, D S Schmidt9, R Ranganath10, R Gill11. 1. Clinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital, Kiskerstraße 26, D-33615 Bielefeld, Germany niels.rahe-meyer@franziskus.de. 2. Duke University School of Medicine, Durham, NC, USA. 3. St Michael's Hospital University of Toronto, Toronto, ON, Canada. 4. Helsinki University Hospital, Helsinki, Finland. 5. Papworth Hospital, Cambridge, UK. 6. Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic. 7. Kobe University Hospital, Kobe, Japan. 8. Nagoya University Graduate School of Medicine, Nagoya, Japan. 9. CSL Behring, Marburg, Germany. 10. CSL Behring, King of Prussia, PA, USA. 11. University Hospital of Southampton, Southampton, UK.
Abstract
BACKGROUND:Single-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. METHODS:Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. RESULTS:519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0-11.0), when compared with placebo, 3.0 (0.0-7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. CONCLUSIONS: Human fibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human fibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.
RCT Entities:
BACKGROUND: Single-dose humanfibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. METHODS:Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. RESULTS: 519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0-11.0), when compared with placebo, 3.0 (0.0-7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. CONCLUSIONS:Humanfibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Humanfibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.
Authors: C Solomon; U Pichlmaier; H Schoechl; C Hagl; K Raymondos; D Scheinichen; W Koppert; N Rahe-Meyer Journal: Br J Anaesth Date: 2010-03-26 Impact factor: 9.166
Authors: James Winearls; Martin Wullschleger; Elizabeth Wake; Catherine Hurn; Jeremy Furyk; Glenn Ryan; Melita Trout; James Walsham; Anthony Holley; Jeremy Cohen; Megan Shuttleworth; Wayne Dyer; Gerben Keijzers; John F Fraser; Jeffrey Presneill; Don Campbell Journal: Trials Date: 2017-05-26 Impact factor: 2.279
Authors: F Lehmann; J Rau; B Malcolm; M Sander; C von Heymann; T Moormann; T Geyer; F Balzer; K D Wernecke; L Kaufner Journal: BMC Anesthesiol Date: 2019-02-18 Impact factor: 2.217