BACKGROUND:Conventional cardiopulmonary bypass (CPB) is associated with increased coagulation and fibrinolytic activity. A closed miniaturized bypass circuit (CorX) features a significantly reduced tubing set, an integrated pump, and an air removal system without a cardiotomy reservoir. In a prospective randomized trial, the effects on hemostasis were investigated while comparing CorX with conventional CPB in patients undergoing coronary artery bypass grafting. METHODS: Over a period of 1 year, 81 patients were randomly assigned either to the CorX system (n = 39, group A) or standard CPB system (n = 42, group B). Primary endpoints were platelet count, plasmin-antiplasmin complex (PAP), prothrombin fragments 1+2 (F1+F2), D-dimers, and fibrinogen. Secondary end-points were hematocrit, blood loss in the first 12 hours postoperatively, transfused packed red blood cells, and fresh frozen plasma in the first 24 hours postoperatively. In addition, we analyzed partial thromboplastin time, prothrombin time, and antithrombin III. RESULTS: After aortic declamping, PAP complex and prothrombin F1+F2 were significantly lower in group A than in group B. The difference in D-dimers between groups reached significance at 1 hour post-CPB. Hematocrit values at the end of CPB measured 26 +/- 6% in group A versus 22 +/- 4% in group B (P = .01). The rest of the observed parameters did not significantly differ between groups. CONCLUSION:Postoperative blood loss was not reduced in the present study. However, the use of the CorX system leads to a significant suppression of activation of coagulation and fibrinolytic cascades compared to conventional CPB, suggesting that miniaturized extracorporeal circuits are a step forward toward reduced imbalance of hemostasis in cardiac surgery.
RCT Entities:
BACKGROUND: Conventional cardiopulmonary bypass (CPB) is associated with increased coagulation and fibrinolytic activity. A closed miniaturized bypass circuit (CorX) features a significantly reduced tubing set, an integrated pump, and an air removal system without a cardiotomy reservoir. In a prospective randomized trial, the effects on hemostasis were investigated while comparing CorX with conventional CPB in patients undergoing coronary artery bypass grafting. METHODS: Over a period of 1 year, 81 patients were randomly assigned either to the CorX system (n = 39, group A) or standard CPB system (n = 42, group B). Primary endpoints were platelet count, plasmin-antiplasmin complex (PAP), prothrombin fragments 1+2 (F1+F2), D-dimers, and fibrinogen. Secondary end-points were hematocrit, blood loss in the first 12 hours postoperatively, transfused packed red blood cells, and fresh frozen plasma in the first 24 hours postoperatively. In addition, we analyzed partial thromboplastin time, prothrombin time, and antithrombin III. RESULTS: After aortic declamping, PAP complex and prothrombin F1+F2 were significantly lower in group A than in group B. The difference in D-dimers between groups reached significance at 1 hour post-CPB. Hematocrit values at the end of CPB measured 26 +/- 6% in group A versus 22 +/- 4% in group B (P = .01). The rest of the observed parameters did not significantly differ between groups. CONCLUSION:Postoperative blood loss was not reduced in the present study. However, the use of the CorX system leads to a significant suppression of activation of coagulation and fibrinolytic cascades compared to conventional CPB, suggesting that miniaturized extracorporeal circuits are a step forward toward reduced imbalance of hemostasis in cardiac surgery.
Authors: Koray Yuruk; Rick Bezemer; Mariska Euser; Dan M J Milstein; Hilde H R de Geus; Evert W Scholten; Bas A J M de Mol; Can Ince Journal: Interact Cardiovasc Thorac Surg Date: 2012-06-14