title: Tranexamic acid compared with high-dose aprotinin in primary elective heart operations: effects on perioperative bleeding and allogeneic transfusions.
abstract: OBJECTIVE
  Since excessive fibrinolysis during cardiac surgery is frequently associated with abnormal perioperative bleeding, many authors have advocated prophylactic use of antifibrinolytic drugs to prevent hemorrhagic disorders. We compared the effects of tranexamic acid (a synthetic antifibrinolytic drug) with aprotinin (a natural derivative product with antifibrinolytic properties) on perioperative bleeding and the need for allogeneic transfusions.
  
  
  METHODS
  In a single-center prospective randomized unblinded trial, 1040 consecutive patients undergoing primary, elective cardiac operations with cardiopulmonary bypass received either high-dose aprotinin or tranexamic acid. The aprotinin group (518 patients) received 280 mg in 20 minutes before the skin incision, 280 mg in the priming solution of the extracorporeal circuit, and a continuous infusion of 70 mg/h throughout the operation. The tranexamic acid group (522 patients) received 1 g in 20 minutes before the skin incision, 500 mg in the priming solution of the extracorporeal circuit, and a continuous infusion of 400 mg/h during the operation. Postoperative bleeding, perioperative transfusions, and hematologic variables were evaluated at fixed times. Postoperative thrombotic complications, intubation time, intensive care unit stay, and hospital stay were recorded.
  
  
  RESULTS
  Postoperative bleeding was similar in the 2 groups: aprotinin 250 mL (150-400 mL) versus tranexamic acid 300 mL (200-450 mL) (median and 25th-75th quartiles), median difference of 50 mL (95% confidence intervals, 0-50 mL). The number of transfusions and the outcome did not differ.
  
  
  CONCLUSIONS
  Tranexamic acid and aprotinin show similar clinical effects on bleeding and allogeneic transfusion in patients undergoing primary elective heart operations. Since tranexamic acid is about 100 times cheaper than aprotinin, its use is preferable in this type of patient.
authors.affiliation: Department of Anesthesiology, University of Milano, Division of Cardiac Anesthesia and Intensive Care, Epidemiology Unit, and Division of Cardiac Surgery, San Raffaele Hospital, Milano, Italy. v_casati@hotmail.com
authors.forename: V
authors.initials: V
authors.lastname: Casati
authors.forename: D
authors.initials: D
authors.lastname: Guzzon
authors.forename: M
authors.initials: M
authors.lastname: Oppizzi
authors.forename: F
authors.initials: F
authors.lastname: Bellotti
authors.forename: A
authors.initials: A
authors.lastname: Franco
authors.forename: C
authors.initials: C
authors.lastname: Gerli
authors.forename: M
authors.initials: M
authors.lastname: Cossolini
authors.forename: G
authors.initials: G
authors.lastname: Torri
authors.forename: G
authors.initials: G
authors.lastname: Calori
authors.forename: S
authors.initials: S
authors.lastname: Benussi
authors.forename: O
authors.initials: O
authors.lastname: Alfieri
mesh_terms: D000933:Antifibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007611:Aprotinin / Q000008:administration & dosage / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D006348:Cardiac Surgical Procedures; D002315:Cardiopulmonary Bypass; D017558:Elective Surgical Procedures; D005260:Female; D006490:Hemostatics / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011292:Premedication; D011446:Prospective Studies; D014148:Tranexamic Acid / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000933:Antifibrinolytic Agents; D006490:Hemostatics; D014148:Tranexamic Acid; D007611:Aprotinin