Biocompatibility of Trillium Biopassive Surface-coated oxygenator versus uncoated oxygenator during cardiopulmonary bypass.
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OBJECTIVE
To determine if the Trillium Biopassive Surface (Medtronic Cardiopulmonary, Minneapolis, MN) coating added to the cardiopulmonary bypass oxygenator reduces inflammatory mediators, blood loss, and transfusion requirements.
METHODS
Prospective, randomized, and blinded human trial.
METHODS
Tertiary care academic medical center.
METHODS
Thirty adult patients undergoing elective coronary artery bypass graft surgery.
METHODS
Patients received visually identical coated or uncoated oxygenators.
RESULTS
Hemoglobin, hematocrit, leukocyte count, platelet count, terminal complement complex, complement activation, myeloperoxidase, beta-thromboglobulin, prothrombin fragment 1.2, plasmin-antiplasmin, heparin concentration, activated coagulation time, and fibrinogen concentration were measured. Blood loss and blood product usage were recorded. In both groups, there were significant inflammatory alterations with the initiation of cardiopulmonary bypass. In the postprotamine samples, the coated oxygenator group had small but significant increases in hemoglobin, hematocrit, and leukocyte count. There were no differences in inflammatory mediators, blood loss, or transfusion requirements between the coated and uncoated groups.
CONCLUSIONS
This human trial of Trillium Biopassive Surface-coated oxygenators did not show clinical benefits or clinically important biochemical results.