Abstract

OBJECTIVES Pericardial lavage with saline, with or without tranexamic acid (TA), is still not evidence-based within current clinical practice as a part of a blood conservation strategy in cardiac surgery patients receiving intravenous TA administration. The objective was to determine whether intravenous TA combined with pericardial lavage with saline, with or without TA, reduces blood loss by 25% after cardiac surgery measured in the first 12 h postoperatively. METHODS In this single-centre, randomized controlled, multiple-armed, parallel study, individual patients were randomly assigned to receive either topical administration of 2 g TA diluted in 200 ml of saline (TA group), 200 ml of saline (placebo group) or no topical administration at all (control group). Eligible participants were all adults aged 18 or older and scheduled for elective cardiac surgery on cardiopulmonary bypass. All patients received 2 g TA intravenously before sternal incision and 2 g TA after cardiopulmonary bypass. The main outcome measure was the 12-h postoperative blood loss. RESULTS In total, 739 individuals were analysed according to intention-to-treat analyses (TA group, n = 245 patients; placebo group, n = 249 patients; control group, n = 245 patients). There was no difference in the median 12-h postoperative blood loss between the three groups [TA group, 290 (IQR 190-430) ml; placebo group, 290 (IQR 210-440) ml; control group, 300 (IQR 190-450) ml, P= 0.759]. CONCLUSIONS Pericardial lavage, with or without TA, does not result in a statistically significant difference in the 12-h postoperative blood loss in cardiac surgery patients receiving intravenous TA administration. Pericardial lavage with saline, with or without TA, should not be a part of a blood conservation strategy.

Abstract

BACKGROUND Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage. METHODS In this multicenter, randomized, blinded trial, we assigned critically ill adults to receive either red cells that had been stored for less than 8 days or standard-issue red cells (the oldest compatible units available in the blood bank). The primary outcome measure was 90-day mortality. RESULTS Between March 2009 and May 2014, at 64 centers in Canada and Europe, 1211 patients were assigned to receive fresh red cells (fresh-blood group) and 1219 patients were assigned to receive standard-issue red cells (standard-blood group). Red cells were stored a mean (+/-SD) of 6.1+/-4.9 days in the fresh-blood group as compared with 22.0+/-8.4 days in the standard-blood group (P<0.001). At 90 days, 448 patients (37.0%) in the fresh-blood group and 430 patients (35.3%) in the standard-blood group had died (absolute risk difference, 1.7 percentage points; 95% confidence interval [CI], -2.1 to 5.5). In the survival analysis, the hazard ratio for death in the fresh-blood group, as compared with the standard-blood group, was 1.1 (95% CI, 0.9 to 1.2; P=0.38). There were no significant between-group differences in any of the secondary outcomes (major illnesses; duration of respiratory, hemodynamic, or renal support; length of stay in the hospital; and transfusion reactions) or in the subgroup analyses. CONCLUSIONS Transfusion of fresh red cells, as compared with standard-issue red cells, did not decrease the 90-day mortality among critically ill adults. (Funded by the Canadian Institutes of Health Research and others; Current Controlled Trials number, ISRCTN44878718.).