OBJECTIVE: The purpose of this study was to compare 2 different doses of ε-aminocaproic acid (EACA) and assess their relative efficacy and safety in children undergoing corrective surgery for tetralogy of Fallot (TOF). DESIGN: A prospective, randomized, controlled study. SETTING: A tertiary care center. PARTICIPANTS: One hundred twenty children undergoing corrective surgery for TOF using cardiopulmonary bypass (CPB). INTERVENTIONS: Group 1 received 100 mg/kg of EACA after induction, upon initiation of CPB, and after protamine. Group 2 received 75 mg/kg of EACA after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB. Group 3 did not receive any antifibrinolytic agent or placebo. MEASUREMENT AND MAIN RESULTS:Cumulative mean blood loss, total packed red blood cells, and fresh frozen plasma requirements were significantly less in group 2 (p ≤ 0.01). There were no significant differences in the total platelet concentrate transfused, re-exploration rate, incidence of renal failure, arrhythmias, neurologic complications, mortality, or length of intensive care unit stay among the 3 groups. The incidences of perioperative ST/T changes and chest closure time were significantly less in group 1 and group 2 (p ≤ 0.01). The duration of mechanical ventilation was significantly less in group 2 (p ≤ 0.01). CONCLUSIONS:EACA was effective in reducing the postoperative blood loss and transfusion requirements in children undergoing corrective cardiac surgery on CPB for TOF. The dose regimen of 75 mg/kg after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB were more effective.
RCT Entities:
OBJECTIVE: The purpose of this study was to compare 2 different doses of ε-aminocaproic acid (EACA) and assess their relative efficacy and safety in children undergoing corrective surgery for tetralogy of Fallot (TOF). DESIGN: A prospective, randomized, controlled study. SETTING: A tertiary care center. PARTICIPANTS: One hundred twenty children undergoing corrective surgery for TOF using cardiopulmonary bypass (CPB). INTERVENTIONS: Group 1 received 100 mg/kg of EACA after induction, upon initiation of CPB, and after protamine. Group 2 received 75 mg/kg of EACA after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB. Group 3 did not receive any antifibrinolytic agent or placebo. MEASUREMENT AND MAIN RESULTS: Cumulative mean blood loss, total packed red blood cells, and fresh frozen plasma requirements were significantly less in group 2 (p ≤ 0.01). There were no significant differences in the total platelet concentrate transfused, re-exploration rate, incidence of renal failure, arrhythmias, neurologic complications, mortality, or length of intensive care unit stay among the 3 groups. The incidences of perioperative ST/T changes and chest closure time were significantly less in group 1 and group 2 (p ≤ 0.01). The duration of mechanical ventilation was significantly less in group 2 (p ≤ 0.01). CONCLUSIONS:EACA was effective in reducing the postoperative blood loss and transfusion requirements in children undergoing corrective cardiac surgery on CPB for TOF. The dose regimen of 75 mg/kg after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB were more effective.