title: Safety and efficacy of prothrombin complex concentrate as first-line treatment in bleeding after cardiac surgery.
abstract: BACKGROUND
  Bleeding after cardiac surgery requiring surgical reexploration and blood component transfusion is associated with increased morbidity and mortality. Although prothrombin complex concentrate (PCC) has been used satisfactorily in bleeding disorders, studies on its efficacy and safety after cardiopulmonary bypass are limited.
  
  
  METHODS
  Between January 2005 and December 2013, 3454 consecutive cardiac surgery patients were included in an observational study aimed at investigating the efficacy and safety of PCC as first-line coagulopathy treatment as a replacement for fresh frozen plasma (FFP). Starting in January 2012, PCC was introduced as solely first-line treatment for bleeding following cardiac surgery.
  
  
  RESULTS
  After one-to-one propensity score-matched analysis, 225 pairs of patients receiving PCC (median dose 1500 IU) and FFP (median dose 2 U) were included. The use of PCC was associated with significantly decreased 24-h post-operative blood loss (836 ± 1226 vs. 935 ± 583 ml, p < 0.0001). Propensity score-adjusted multivariate analysis showed that PCC was associated with significantly lower risk of red blood cell (RBC) transfusions (odds ratio [OR] 0.50; 95% confidence interval [CI] 0.31-0.80), decreased amount of RBC units (β unstandardised coefficient -1.42, 95% CI -2.06 to -0.77) and decreased risk of transfusion of more than 2 RBC units (OR 0.53, 95% CI 0.38-0.73). Patients receiving PCC had an increased risk of post-operative acute kidney injury (AKI) (OR 1.44, 95% CI 1.02-2.05) and renal replacement therapy (OR 3.35, 95% CI 1.13-9.90). Hospital mortality was unaffected by PCC (OR 1.51, 95% CI 0.84-2.72).
  
  
  CONCLUSIONS
  In the cardiac surgery setting, the use of PCC compared with FFP was associated with decreased post-operative blood loss and RBC transfusion requirements. However, PCC administration may be associated with a higher risk of post-operative AKI.
authors.affiliation: Department of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. giangiuseppe.cappabianca@ospedale.varese.it.
authors.forename: Giangiuseppe
authors.initials: G
authors.lastname: Cappabianca
authors.affiliation: Department of Cardiovascular Sciences, Clinical Sciences Wing, Glenfield Hospital, University of Leicester, Groby Road, Leicester, LE39QP, UK. giovannimariscalco@yahoo.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mariscalco
authors.affiliation: Department of Surgery, Oulu University Hospital, Oulu, Finland. faustobiancari@yahoo.it.
authors.forename: Fausto
authors.initials: F
authors.lastname: Biancari
authors.affiliation: Department of Cardiovascular Surgery, Cardiac Surgery Unit, S.Anna Hospital Catanzaro, Catanzaro, Italy. 4maselli@gmail.com.
authors.forename: Daniele
authors.initials: D
authors.lastname: Maselli
authors.affiliation: Department of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. f.papesso@hotmail.com.
authors.forename: Francesca
authors.initials: F
authors.lastname: Papesso
authors.affiliation: Department of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. marzia.cottini@hotmail.it.
authors.forename: Marzia
authors.initials: M
authors.lastname: Cottini
authors.affiliation: Cardiac Intensive Care Unit, Varese University Hospital, University of Insubria, Varese, Italy. sandro.crosta@ospedale.varese.it.
authors.forename: Sandro
authors.initials: S
authors.lastname: Crosta
authors.affiliation: Cardiac Intensive Care Unit, Varese University Hospital, University of Insubria, Varese, Italy. simona.banescu@ospedale.varese.it.
authors.forename: Simona
authors.initials: S
authors.lastname: Banescu
authors.affiliation: Department of Anaesthesia and Critical Care, Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK. aamer.ahmed@uhl-tr.nhs.uk.
authors.forename: Aamer B
authors.initials: AB
authors.lastname: Ahmed
authors.affiliation: Department of Surgical and Morphological Sciences, Cardiac Surgery Unit, Varese University Hospital, University of Insubria, Varese, Italy. cesare.beghi@uninsubria.it.
authors.forename: Cesare
authors.initials: C
authors.lastname: Beghi
mesh_terms: D000368:Aged; D001779:Blood Coagulation Factors / Q000009:adverse effects* / Q000627:therapeutic use*; D016913:Blood Component Transfusion / Q000009:adverse effects; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D017707:Erythrocyte Transfusion / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010949:Plasma; D057216:Propensity Score; D019616:Thoracic Surgical Procedures / Q000379:methods*; D013997:Time Factors
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates