OBJECTIVE: To assess tolerance and preliminary efficacy of a perfluorocarbon emulsion (AF0144) used with acute normovolemic hemodilution to reduce allogeneic blood transfusion for patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). DESIGN: Controlled, single-blind, parallel-group phase II dose escalation trial. SETTING:Single-institution university medical center. PARTICIPANTS: Adult patients undergoing elective CABG surgery (n = 36). INTERVENTIONS: A calculated volume of autologous whole blood was harvested for each patient with a target on-bypass hematocrit of 20% to 22%. Placebo, low-dose (1.8 g/kg) AF0144, or high-dose (2.7 g/kg) AF0144 was infused. During CPB, blood was transfused at protocol-defined triggers (hematocrit <15%, PvO(2) <30 mmHg, SvO(2) <60%). After CPB, all autologous whole blood was reinfused. Allogeneic red blood cells were transfused if a trigger was reached. MEASUREMENTS AND MAIN RESULTS:Safety assessments (vital signs, hematology, blood chemistry, coagulation, and adverse events) were monitored through postoperative day 21. Efficacy endpoints included percentage of patients reaching a transfusion trigger and number of allogeneic units of red blood cells transfused. During CPB, <25% of subjects reached a transfusion trigger. During hospitalization, significantly fewer (p < 0.01) high-dose subjects (33%) reached a trigger than did control patients (91%). Allogeneic red blood cell transfusion did not differ significantly among groups. Safety assessments indicated AF0144 was well tolerated. CONCLUSION: The data suggest that AF0144 when used with acute normovolemic hemodilution is well tolerated and may be effective when used to enhance oxygen delivery for patients undergoing CABG surgery. Confirmation of safety and efficacy in a larger phase III clinical trial is warranted. Copyright 2002, Elsevier Science (USA). All rights reserved.
RCT Entities:
OBJECTIVE: To assess tolerance and preliminary efficacy of a perfluorocarbon emulsion (AF0144) used with acute normovolemic hemodilution to reduce allogeneic blood transfusion for patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). DESIGN: Controlled, single-blind, parallel-group phase II dose escalation trial. SETTING: Single-institution university medical center. PARTICIPANTS: Adult patients undergoing elective CABG surgery (n = 36). INTERVENTIONS: A calculated volume of autologous whole blood was harvested for each patient with a target on-bypass hematocrit of 20% to 22%. Placebo, low-dose (1.8 g/kg) AF0144, or high-dose (2.7 g/kg) AF0144 was infused. During CPB, blood was transfused at protocol-defined triggers (hematocrit <15%, PvO(2) <30 mmHg, SvO(2) <60%). After CPB, all autologous whole blood was reinfused. Allogeneic red blood cells were transfused if a trigger was reached. MEASUREMENTS AND MAIN RESULTS: Safety assessments (vital signs, hematology, blood chemistry, coagulation, and adverse events) were monitored through postoperative day 21. Efficacy endpoints included percentage of patients reaching a transfusion trigger and number of allogeneic units of red blood cells transfused. During CPB, <25% of subjects reached a transfusion trigger. During hospitalization, significantly fewer (p < 0.01) high-dose subjects (33%) reached a trigger than did control patients (91%). Allogeneic red blood cell transfusion did not differ significantly among groups. Safety assessments indicated AF0144 was well tolerated. CONCLUSION: The data suggest that AF0144 when used with acute normovolemic hemodilution is well tolerated and may be effective when used to enhance oxygen delivery for patients undergoing CABG surgery. Confirmation of safety and efficacy in a larger phase III clinical trial is warranted. Copyright 2002, Elsevier Science (USA). All rights reserved.