title: The safety and efficacy of antifibrinolytic therapy in neonatal cardiac surgery.
abstract: BACKGROUND
  Neonates undergoing open-heart surgery are particularly at risk of postoperative bleeding requiring blood transfusion. Aprotinin has attained high efficacy in reducing the requirement for a blood transfusion following a cardiopulmonary bypass, but is seldom studied in the neonatal age group. The aim of this study was to compare the efficacy and adverse effects of aprotinin and tranexamic acid in neonates undergoing open-heart surgery at a single centre.
  
  
  METHODS
  Between October 2003 and March 2008, perioperative data of 552 consecutive neonatal patients undergoing open-heart surgery in Children's Hospital Boston were reviewed. Among them, 177 did not receive antifibrinolytic therapy (Group A); 100 were treated with tranexamic acid only (Group B); and 275 patients received aprotinin with or without tranexamic acid (Group C). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained identical. Postoperative complications and in-hospital mortality were the primary study endpoints.
  
  
  RESULTS
  Body weight and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores were statistically comparable among the three groups. No statistically significant differences were observed between the duration of hospitalization, chest tube drainage, reexploration for bleeding, and kidney function impairment. In Group C, less blood was transfused within 24 hours than in GroupB. Operative mortality was similar among the three groups.
  
  
  CONCLUSIONS
  No further risk and kidney injury were observed in the use of aprotinin in neonatal cardiac surgery, aprotinin demonstrated a reduced requirement for blood transfusion compared with tranexamic acid. Our data provide reasonable evidence that aprotinin and tranexamic acid are safe and efficacious as antifibrinolytic modalities in neonatal patients undergoing cardiac surgery.
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America; Division of Cardiovascular Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
authors.forename: Chih-Yuan
authors.initials: CY
authors.lastname: Lin
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Jeffery H
authors.initials: JH
authors.lastname: Shuhaiber
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Hugo
authors.initials: H
authors.lastname: Loyola
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Hua
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Pedro
authors.initials: P
authors.lastname: Del Nido
authors.affiliation: Department of Anaesthesia, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: James A
authors.initials: JA
authors.lastname: DiNardo
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Frank A
authors.initials: FA
authors.lastname: Pigula
mesh_terms: D000933:Antifibrinolytic Agents / Q000009:adverse effects*; D007611:Aprotinin / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D008297:Male; D012189:Retrospective Studies; D014148:Tranexamic Acid / Q000009:adverse effects*
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid; D007611:Aprotinin