title: A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts.
abstract: BACKGROUND
  A multicenter, randomized, controlled, open-label trial was conducted to evaluate the safety and efficacy of Celsior when used for flush and hypothermic storage of donor hearts before transplantation.
  
  
  METHODS
  Heart transplant recipients were randomized to one of two treatment groups in which donor hearts were flushed and stored in either Celsior or conventional preservation solution(s) (control). Study subjects were followed 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%), but the difference was not statistically significant based on 95% confidence interval analysis. No significant difference was measured between the Celsior and control groups in 7-day patient survival (97% versus 94%) and the proportion of patients with one or more adverse events (Celsior, 88%; control 87%) or serious adverse events (Celsior, 38%; control, 46%). Significantly fewer patients in the Celsior group developed at least one cardiac-related serious adverse event (13% versus 25%).
  
  
  CONCLUSIONS
  Celsior was demonstrated to be as safe and effective as conventional solutions for flush and cold storage of cardiac allografts before transplantation.
authors.affiliation: Emory University Hospital, Atlanta, Georgia, USA. david_vega@emory.org
authors.forename: J D
authors.initials: JD
authors.lastname: Vega
authors.forename: J L
authors.initials: JL
authors.lastname: Ochsner
authors.forename: V
authors.initials: V
authors.lastname: Jeevanandam
authors.forename: D C
authors.initials: DC
authors.lastname: McGiffin
authors.forename: K R
authors.initials: KR
authors.lastname: McCurry
authors.forename: R M
authors.initials: RM
authors.lastname: Mentzer
authors.forename: J C
authors.initials: JC
authors.lastname: Stringham
authors.forename: R N
authors.initials: RN
authors.lastname: Pierson
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
authors.forename: A H
authors.initials: AH
authors.lastname: Menkis
authors.forename: E D
authors.initials: ED
authors.lastname: Staples
authors.forename: D L
authors.initials: DL
authors.lastname: Modry
authors.forename: R W
authors.initials: RW
authors.lastname: Emery
authors.forename: W
authors.initials: W
authors.lastname: Piccione
authors.forename: M
authors.initials: M
authors.lastname: Carrier
authors.forename: P J
authors.initials: PJ
authors.lastname: Hendry
authors.forename: S
authors.initials: S
authors.lastname: Aziz
authors.forename: S
authors.initials: S
authors.lastname: Furukawa
authors.forename: S M
authors.initials: SM
authors.lastname: Pham
mesh_terms: D000328:Adult; D000368:Aged; D002314:Cardioplegic Solutions; D015925:Cryopreservation; D004187:Disaccharides; D004573:Electrolytes; D005260:Female; D005500:Follow-Up Studies; D005971:Glutamates; D005978:Glutathione; D006084:Graft Rejection / Q000401:mortality; D006085:Graft Survival; D016027:Heart Transplantation; D006639:Histidine; D006801:Humans; D008297:Male; D008353:Mannitol; D009926:Organ Preservation; D011183:Postoperative Complications / Q000401:mortality; D014184:Transplantation, Homologous
chemical_list: D002314:Cardioplegic Solutions; C088453:Celsior; D004187:Disaccharides; D004573:Electrolytes; D005971:Glutamates; D008353:Mannitol; D006639:Histidine; D005978:Glutathione