BACKGROUND: Drawbacks of conventional cardiopulmonary bypass (CPB) are increased inflammatory response, deteriorated coagulation and systemic organ dysfunction. A closed extracorporeal circuit (CorX) features reduced foreign surface area and priming volume. Potential benefits were studied in comparing the CorX system with conventional CPB in arrested heart coronary artery bypass grafting (CABG). METHODS:Two hundred and four patients were randomly assigned either to CorX system (n = 101, group A) or a standard CPB with cardiotomy reservoir (n = 103, group B). Besides evaluation of perioperative data and routine blood samples, we focused on lung function and perioperative bleeding. Polymorphonuclear elastase (PMNE) and terminal complement complex (TCC) served to assess inflammatory response. RESULTS: Patient demographics and operative data did not differ between groups. Postoperative lung function was not significantly impaired comparing groups A and B. Intraoperative blood loss was significantly higher in group A compared with group B (1245 +/- 947 mL vs 313 +/- 282 mL, p < 0.0001) as well as the need of fresh frozen plasma. Postoperative chest drainage did not differ significantly between groups. Two patients in each group required re-exploration due to bleeding. One hour after CPB, PMNE as well as TCC were significantly lower in group A compared with group B (PMNE: 76 +/- 44 ng/mL vs 438 +/- 230 ng/mL, p < 0.0001; TCC: 16 +/- 8 IU/mL vs 29 +/- 19 IU/mL, p < 0.0001). CONCLUSIONS: The CorX system is safe and feasible in patients undergoing CABG. Despite of markedly reduced inflammatory reaction, no clinical benefit was observed.
RCT Entities:
BACKGROUND: Drawbacks of conventional cardiopulmonary bypass (CPB) are increased inflammatory response, deteriorated coagulation and systemic organ dysfunction. A closed extracorporeal circuit (CorX) features reduced foreign surface area and priming volume. Potential benefits were studied in comparing the CorX system with conventional CPB in arrested heart coronary artery bypass grafting (CABG). METHODS: Two hundred and four patients were randomly assigned either to CorX system (n = 101, group A) or a standard CPB with cardiotomy reservoir (n = 103, group B). Besides evaluation of perioperative data and routine blood samples, we focused on lung function and perioperative bleeding. Polymorphonuclear elastase (PMNE) and terminal complement complex (TCC) served to assess inflammatory response. RESULTS:Patient demographics and operative data did not differ between groups. Postoperative lung function was not significantly impaired comparing groups A and B. Intraoperative blood loss was significantly higher in group A compared with group B (1245 +/- 947 mL vs 313 +/- 282 mL, p < 0.0001) as well as the need of fresh frozen plasma. Postoperative chest drainage did not differ significantly between groups. Two patients in each group required re-exploration due to bleeding. One hour after CPB, PMNE as well as TCC were significantly lower in group A compared with group B (PMNE: 76 +/- 44 ng/mL vs 438 +/- 230 ng/mL, p < 0.0001; TCC: 16 +/- 8 IU/mL vs 29 +/- 19 IU/mL, p < 0.0001). CONCLUSIONS: The CorX system is safe and feasible in patients undergoing CABG. Despite of markedly reduced inflammatory reaction, no clinical benefit was observed.
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