Trillium-coated oxygenators in adult open-heart surgery: a prospective randomized trial.
This randomized, prospective clinical trial examines the impact of the use of Trillium biopassive surface coating on clinical outcomes after cardiopulmonary bypass (CPB) that may be induced by contact of blood elements with foreign surfaces. The study consisted of 98 consecutive patients randomly assigned to either a CPB circuit that consisted of a Trillium-coated Affinity open reservoir oxygenator or a CPB circuit with an uncoated Affinity open reservoir oxygenator. The operative procedure performed on all 98 patients consisted of either coronary artery bypass graft (CABG), valve, or a combination of the two. Exclusion criteria consisted of patients who presented to the operating room in circulatory arrest. Trillium biopassive surface coating resulted in improved clinical outcomes and fewer adverse events when compared to the control group. Significantly, fewer patients required no blood products (18.3% in the control group vs. 32.7% in the treatment group), even though the control group had a significantly higher pre-bypass hematocrit. Postoperative atrial fibrillation (24.5% vs. 16.3%) and reoperation for bleeding (10.2% vs. 4.1%) showed a much lower incidence in the Trillium group. Significance was not reached because of the small sample size resulting in low power. Trillium circuits result in improved patient outcomes in the treatment group when compared to the control circuit group.
Dickinson
Timothy
T
FMC-Extracorporeal Alliance, Pontiac, Michigan, USA. Tim.Dickinson@fmc-na.com
Mahoney
C B
CB
Simmons
Mark
M
Marison
Angela
A
Polanski
Paul
P
D000368:Aged; D002315:Cardiopulmonary Bypass / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010106:Oxygenators; D011182:Postoperative Care; D011446:Prospective Studies; D016896:Treatment Outcome; D031446:Trillium; D014481:United States
D020099:Coated Materials, Biocompatible