SUMMARY BACKGROUND: Infusion of artificial colloids such as hydroxyethyl starch (HES) induces coagulopathy to a greater extent than simple dilution. Several studies have suggested that the coagulopathy could be corrected by substitution with a fibrinogen concentrate. OBJECTIVES: The aims of the present prospective, randomized, placebo-controlled trial were to investigate the hemostatic effect of a fibrinogen concentrate after coagulopathy induced by hydroxyethyl starch in patients experiencing sudden excessive bleeding during elective cystectomy. METHODS:Twenty patients were included. Blood loss was substituted 1:1 with HES 130/0.4. At a dilution level of 30%, patients were randomly selected for intra-operative administration of a fibrinogen concentrate or placebo. The primary endpoint was maximum clot firmness (MCF), as assessed by thromboelastometry. Secondary endpoints were blood loss and transfusion requirements, other thromboelastometry parameters, thrombin generation and platelet function. RESULTS:Whole-blood MCF was significantly reduced after 30% dilution in vivo with HES. The placebo resulted in a further decline of the MCF, whereas randomized administration of fibrinogen significantly increased the MCF. Furthermore, only 2 out of 10 patients randomly chosen to receive fibrinogen substitution required postoperative red blood cell transfusions, compared with 8 out of 10 in the placebo group (P = 0.023). Platelet function and thrombin generation were reduced after 30% hemodilution in vivo, and fibrinogen administration caused no significant changes. CONCLUSIONS: During cystectomy, fluid resuscitation with HES 130/0.4 during sudden excessive bleeding induces coagulopathy that shows reduced whole-blood maximum clot firmness. Randomized administration of fibrinogen concentrate significantly improved maximum clot firmness and reduced the requirement for postoperative transfusion.
RCT Entities:
SUMMARY BACKGROUND: Infusion of artificial colloids such as hydroxyethyl starch (HES) induces coagulopathy to a greater extent than simple dilution. Several studies have suggested that the coagulopathy could be corrected by substitution with a fibrinogen concentrate. OBJECTIVES: The aims of the present prospective, randomized, placebo-controlled trial were to investigate the hemostatic effect of a fibrinogen concentrate after coagulopathy induced by hydroxyethyl starch in patients experiencing sudden excessive bleeding during elective cystectomy. METHODS: Twenty patients were included. Blood loss was substituted 1:1 with HES 130/0.4. At a dilution level of 30%, patients were randomly selected for intra-operative administration of a fibrinogen concentrate or placebo. The primary endpoint was maximum clot firmness (MCF), as assessed by thromboelastometry. Secondary endpoints were blood loss and transfusion requirements, other thromboelastometry parameters, thrombin generation and platelet function. RESULTS: Whole-blood MCF was significantly reduced after 30% dilution in vivo with HES. The placebo resulted in a further decline of the MCF, whereas randomized administration of fibrinogen significantly increased the MCF. Furthermore, only 2 out of 10 patients randomly chosen to receive fibrinogen substitution required postoperative red blood cell transfusions, compared with 8 out of 10 in the placebo group (P = 0.023). Platelet function and thrombin generation were reduced after 30% hemodilution in vivo, and fibrinogen administration caused no significant changes. CONCLUSIONS: During cystectomy, fluid resuscitation with HES 130/0.4 during sudden excessive bleeding induces coagulopathy that shows reduced whole-blood maximum clot firmness. Randomized administration of fibrinogen concentrate significantly improved maximum clot firmness and reduced the requirement for postoperative transfusion.
Authors: John B Holcomb; Erin E Fox; Xuan Zhang; Nathan White; Charles E Wade; Bryan A Cotton; Deborah J del Junco; Eileen M Bulger; Mitchell J Cohen; Martin A Schreiber; John G Myers; Karen J Brasel; Herb A Phelan; Louis H Alarcon; Peter Muskat; Mohammad H Rahbar Journal: J Trauma Acute Care Surg Date: 2013-07 Impact factor: 3.313
Authors: Santiago R Leal-Noval; Manuel Muñoz; Marisol Asuero; Enric Contreras; José A García-Erce; Juan V Llau; Victoria Moral; José A Páramo; Manuel Quintana Journal: Blood Transfus Date: 2013-06-17 Impact factor: 3.443
Authors: Christoph Johannes Schlimp; Janne Cadamuro; Cristina Solomon; Heinz Redl; Herbert Schöchl Journal: Blood Transfus Date: 2012-12-13 Impact factor: 3.443
Authors: Maik Sossdorf; Sascha Marx; Barbara Schaarschmidt; Gordon P Otto; Ralf A Claus; Konrad Reinhart; Christiane S Hartog; Wolfgang Lösche Journal: Crit Care Date: 2009-12-22 Impact factor: 9.097
Authors: Oliver Grottke; Till Braunschweig; Dietrich Henzler; Mark Coburn; Rene Tolba; Rolf Rossaint Journal: Crit Care Date: 2010-04-14 Impact factor: 9.097
Authors: Rolf Rossaint; Bertil Bouillon; Vladimir Cerny; Timothy J Coats; Jacques Duranteau; Enrique Fernández-Mondéjar; Beverley J Hunt; Radko Komadina; Giuseppe Nardi; Edmund Neugebauer; Yves Ozier; Louis Riddez; Arthur Schultz; Philip F Stahel; Jean-Louis Vincent; Donat R Spahn Journal: Crit Care Date: 2010-04-06 Impact factor: 9.097