A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts

Background. A multicenter, randomized, controlled, open-label trial was con ducted to evaluate the safety and efficacy of Celsior when used for flush a nd hypothermic storage of donor hearts before transplantation. Methods. Heart transplant recipients were randomized to one of two treatmen t groups in which donor hearts were flushed and stored in either Celsior or conventional preservation solution(s) (control). Study subjects were follo wed for 30 days after transplantation. Results. A total of 131 heart transplant recipients were enrolled (Celsior, n = 64; control, n = 67). The treatment groups were evenly distributed in donor and recipient base line characteristics. Graft loss rate was lower in the Celsior group on day 7 (3% versus 9%) and on day 30 (6% versus 13%), b ut the difference was not statistically significant based on 95% confidence interval analysis. No significant difference was measured between the Cels ior and control groups in 7-day patient survival (97% versus 94%) and the p roportion of patients with one or more adverse events (Celsior, 88%; contro l 87%) or serious adverse events (Celsior, 38%; control, 46%). Significantl y fewer patients in the Celsior group developed at least one cardiac-relate d serious adverse event (13% versus 25%). Conclusions. Celsior was demonstrated to be as safe and effective as conven tional solutions for flush and cold storage of cardiac allografts before tr ansplantation. (Ann Thorac Surg 2001;71:1442-7) (C) 2001 by The Society of Thoracic Surgeons.