title: Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery.
abstract: OBJECTIVE
  Coagulopathy is an important cause of bleeding after complex cardiac surgery. The conventional treatment for coagulopathy is transfusion, which is associated with adverse outcomes. We report our initial experience with the prothrombin complex concentrate FEIBA (factor VIII inhibitor bypassing activity) for the rescue treatment of coagulopathy and life-threatening bleeding after cardiac surgery.
  
  
  METHODS
  Twenty-five patients who underwent cardiac surgery with coagulopathy and life-threatening bleeding refractory to conventional treatment received FEIBA as rescue therapy at our institution. This cohort represents approximately 2% of patients undergoing cardiac surgery in our university-based practice during the study.
  
  
  RESULTS
  The patients were at high risk for postoperative coagulopathy with nearly all patients having at least 2 risk factors for this. Aortic root replacement (Bentall or valve-sparing procedure) and heart transplant with or without left ventricular assist device explant were the most common procedures. The mean FEIBA dose was 2154 units. The need for fresh frozen plasma and platelet transfusion decreased significantly after FEIBA administration (P = .0001 and P < .0001). The mean internationalized normalized ratio decreased from 1.58 to 1.13 (P < .0001). Clinical outcomes were excellent. No patient returned to the operating room for reexploration. There was no hospital mortality and all patients were discharged home. One patient who had a central line and transvenous pacemaker developed an upper extremity deep vein thrombosis.
  
  
  CONCLUSIONS
  Our initial experience with FEIBA administration for the rescue treatment of postoperative coagulopathy and life-threatening bleeding has been favorable. Further studies are indicated to confirm its efficacy and safety and determine specific clinical indications for its use in patients undergoing cardiac surgery.
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore. Electronic address: songh@ohsu.edu.
authors.forename: Howard K
authors.initials: HK
authors.lastname: Song
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Tibayan
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Ed A
authors.initials: EA
authors.lastname: Kahl
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Valerie A
authors.initials: VA
authors.lastname: Sera
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Slater
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Deloughery
authors.affiliation: Division of Cardiothoracic Surgery, Department of Anesthesiology and Perioperative Medicine, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland, Ore.
authors.forename: Mick M
authors.initials: MM
authors.lastname: Scanlan
mesh_terms: D000328:Adult; D000368:Aged; D001777:Blood Coagulation / Q000187:drug effects*; D001779:Blood Coagulation Factors / Q000009:adverse effects / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D017713:Platelet Transfusion; D019106:Postoperative Hemorrhage / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001779:Blood Coagulation Factors; D003029:Coagulants; C025667:prothrombin complex concentrates