Perflubron emulsion (AF0144) augments harvesting of autologous blood: a phase II study in cardiac surgery.
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).


METHODS
Controlled, single-blind, parallel-group phase II dose escalation trial.


METHODS
Single-institution university medical center.


METHODS
Adult patients undergoing elective CABG surgery (n = 36).


METHODS
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.


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.


CONCLUSIONS
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.
Hill
Steven E
SE
Department of Anesthesiology, Duke University Medical Center, Durham, NC 27710, USA. hill0012@mc.duke.edu
Leone
Bruce J
BJ
Faithfull
N Simon
NS
Flaim
Kathy E
KE
Keipert
Peter E
PE
Newman
Mark F
MF
D000328:Adult; D000368:Aged; D001803:Blood Transfusion; D002315:Cardiopulmonary Bypass; D001026:Coronary Artery Bypass; D005260:Female; D005466:Fluorocarbons / Q000009:adverse effects / Q000494:pharmacology*; D006438:Hemodilution / Q000379:methods*; D006801:Humans; D006842:Hydrocarbons, Brominated; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method
D005466:Fluorocarbons; D006842:Hydrocarbons, Brominated; C003072:perflubron