title: Replacement of aprotinin by ε-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome.
abstract: BACKGROUND
  Once aprotinin was no longer available for clinical use, ε-aminocaproic acid (EACA) and tranexamic acid became the only two options for antifibrinolytic therapy. We compared aprotinin and EACA with respect to their blood-sparing efficacy and other major clinical outcome criteria in infants undergoing cardiac surgery.
  
  
  METHODS
  We retrospectively analysed data from a large consecutive cohort of infants (n=227) aged 31-365 days undergoing primary cardiac surgery requiring cardiopulmonary bypass encompassing the transition from aprotinin to EACA (aprotinin n=88, EACA n=139); all other aspects including the medical team and departmental protocols remained unchanged. The primary outcome was postoperative blood loss measured as chest tube output (CTO). Secondary outcome parameters were transfusion requirements, reoperation due to bleeding, renal, vascular, and neurological complications, and in-hospital mortality.
  
  
  RESULTS
  CTO was significantly higher in the EACA patients {aprotinin 18 (13-27) ml kg(-1) 24 h(-1), EACA 23 (15-37) ml kg(-1) 24 h(-1) [mean (inter-quartile range)], P=0.001}, but transfusion requirements and donor exposures were not significantly different. A sensitivity analysis strengthened our finding that the increased blood loss in the EACA group was attributable to lower efficacy of EACA. There were no significant differences in the other clinical outcome measures.
  
  
  CONCLUSIONS
  CTO was lower in aprotinin-treated patients. Nonetheless, EACA remains a suitable substitute without measurable differences in other clinical outcome criteria.
authors.affiliation: Department of Anaesthesiology, Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Munich, Germany. martin@dhm.mhn.de
authors.forename: K
authors.initials: K
authors.lastname: Martin
authors.forename: R
authors.initials: R
authors.lastname: Gertler
authors.forename: M
authors.initials: M
authors.lastname: MacGuill
authors.forename: N P
authors.initials: NP
authors.lastname: Mayr
authors.forename: A
authors.initials: A
authors.lastname: Hapfelmeier
authors.forename: J
authors.initials: J
authors.lastname: Hörer
authors.forename: M
authors.initials: M
authors.lastname: Vogt
authors.forename: P
authors.initials: P
authors.lastname: Tassani
authors.forename: G
authors.initials: G
authors.lastname: Wiesner
mesh_terms: D015119:Aminocaproic Acid / Q000627:therapeutic use*; D007611:Aprotinin / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D006348:Cardiac Surgical Procedures / Q000379:methods*; D015505:Chest Tubes; D001026:Coronary Artery Bypass; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D017052:Hospital Mortality; D006801:Humans; D007223:Infant; D008297:Male; D061214:Patient Safety; D011183:Postoperative Complications / Q000453:epidemiology; D020379:Risk Adjustment; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D007611:Aprotinin; D015119:Aminocaproic Acid