Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: A randomized, placebo-controlled, multicenter clinical trial

Keyvan Karkouti, Christian Von Heymann, Christian M. Jespersen, Wolfgang Korte, Jerrold H. Levy, Marco Ranucci, Frank W. Sellke, Howard Song

    Research output: Contribution to journalArticle

    43 Citations (Scopus)

    Abstract

    Objectives: Cardiac surgery with cardiopulmonary bypass frequently leads to excessive bleeding, obligating blood product transfusions. Because low factor XIII (FXIII) levels have been associated with bleeding after cardiac surgery, we investigated whether administering recombinant FXIII after cardiopulmonary bypass would reduce transfusions. Methods: In this double-blinded, placebo-controlled, multicenter trial, 409 cardiac surgical patients at moderate risk for transfusion were randomized to receive an intravenous dose of recombinant FXIII, 17.5 IU/kg (n = 143), 35 IU/kg (n = 138), or placebo (n = 128) after cardiopulmonary bypass. Transfusion guidelines were standardized. The primary efficacy outcome was avoidance of allogeneic blood products for 7 days postsurgery. Secondary outcomes included amount of blood products transfused and reoperation rate. Serious adverse events were measured for 7 weeks. Results: Study groups had comparable baseline characteristics and an approximately 40% decrease in FXIII levels after cardiopulmonary bypass. Thirty minutes postdose, FXIII levels were restored to higher than the lower 2.5th percentile of preoperative activity in 49% of the placebo group, and 85% and 95% of the 17.5- and 35-IU/kg recombinant FXIII groups, respectively (P

    Original languageEnglish (US)
    Pages (from-to)927-939
    Number of pages13
    JournalJournal of Thoracic and Cardiovascular Surgery
    Volume146
    Issue number4
    DOIs
    StatePublished - Oct 2013

    Fingerprint

    Factor XIII
    Controlled Clinical Trials
    Blood Transfusion
    Thoracic Surgery
    Multicenter Studies
    Placebos
    Cardiopulmonary Bypass
    Safety
    Hemorrhage
    Reoperation
    Guidelines

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine
    • Surgery
    • Pulmonary and Respiratory Medicine

    Cite this

    Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery : A randomized, placebo-controlled, multicenter clinical trial. / Karkouti, Keyvan; Von Heymann, Christian; Jespersen, Christian M.; Korte, Wolfgang; Levy, Jerrold H.; Ranucci, Marco; Sellke, Frank W.; Song, Howard.

    In: Journal of Thoracic and Cardiovascular Surgery, Vol. 146, No. 4, 10.2013, p. 927-939.

    Research output: Contribution to journalArticle

    Karkouti, Keyvan ; Von Heymann, Christian ; Jespersen, Christian M. ; Korte, Wolfgang ; Levy, Jerrold H. ; Ranucci, Marco ; Sellke, Frank W. ; Song, Howard. / Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery : A randomized, placebo-controlled, multicenter clinical trial. In: Journal of Thoracic and Cardiovascular Surgery. 2013 ; Vol. 146, No. 4. pp. 927-939.
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    abstract = "Objectives: Cardiac surgery with cardiopulmonary bypass frequently leads to excessive bleeding, obligating blood product transfusions. Because low factor XIII (FXIII) levels have been associated with bleeding after cardiac surgery, we investigated whether administering recombinant FXIII after cardiopulmonary bypass would reduce transfusions. Methods: In this double-blinded, placebo-controlled, multicenter trial, 409 cardiac surgical patients at moderate risk for transfusion were randomized to receive an intravenous dose of recombinant FXIII, 17.5 IU/kg (n = 143), 35 IU/kg (n = 138), or placebo (n = 128) after cardiopulmonary bypass. Transfusion guidelines were standardized. The primary efficacy outcome was avoidance of allogeneic blood products for 7 days postsurgery. Secondary outcomes included amount of blood products transfused and reoperation rate. Serious adverse events were measured for 7 weeks. Results: Study groups had comparable baseline characteristics and an approximately 40{\%} decrease in FXIII levels after cardiopulmonary bypass. Thirty minutes postdose, FXIII levels were restored to higher than the lower 2.5th percentile of preoperative activity in 49{\%} of the placebo group, and 85{\%} and 95{\%} of the 17.5- and 35-IU/kg recombinant FXIII groups, respectively (P",
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    AU - Von Heymann, Christian

    AU - Jespersen, Christian M.

    AU - Korte, Wolfgang

    AU - Levy, Jerrold H.

    AU - Ranucci, Marco

    AU - Sellke, Frank W.

    AU - Song, Howard

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    N2 - Objectives: Cardiac surgery with cardiopulmonary bypass frequently leads to excessive bleeding, obligating blood product transfusions. Because low factor XIII (FXIII) levels have been associated with bleeding after cardiac surgery, we investigated whether administering recombinant FXIII after cardiopulmonary bypass would reduce transfusions. Methods: In this double-blinded, placebo-controlled, multicenter trial, 409 cardiac surgical patients at moderate risk for transfusion were randomized to receive an intravenous dose of recombinant FXIII, 17.5 IU/kg (n = 143), 35 IU/kg (n = 138), or placebo (n = 128) after cardiopulmonary bypass. Transfusion guidelines were standardized. The primary efficacy outcome was avoidance of allogeneic blood products for 7 days postsurgery. Secondary outcomes included amount of blood products transfused and reoperation rate. Serious adverse events were measured for 7 weeks. Results: Study groups had comparable baseline characteristics and an approximately 40% decrease in FXIII levels after cardiopulmonary bypass. Thirty minutes postdose, FXIII levels were restored to higher than the lower 2.5th percentile of preoperative activity in 49% of the placebo group, and 85% and 95% of the 17.5- and 35-IU/kg recombinant FXIII groups, respectively (P

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