Dorien M Kimenai1, Bastiaan M Gerritse2, Cees Lucas3, Peter M Rosseel2, Mohamed Bentala4, Paul van Hattum5, Nardo J M van der Meer2, Thierry V Scohy6. 1. Department of Extracorporeal Circulation, Amphia Hospital, Breda, Netherlands. 2. Department of Anesthesiology, Amphia Hospital, Breda, Netherlands. 3. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical University Centre of Amsterdam, Amsterdam, Netherlands. 4. Department of Cardiothoracic Surgery, Amphia Hospital, Breda, Netherlands. 5. Department of Clinical Pharmacology, Amphia Hospital, Breda, Netherlands. 6. Department of Anesthesiology, Amphia Hospital, Breda, Netherlands tscohy@amphia.nl.
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.
RCT Entities:
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.