Local and systemic application of tranexamic acid in heart valve surgery: a prospective, randomized, double blind LOST study

Abstract

The study was performed to examine a possible augmentation of systemic administration of tranexamic acid by the additional topical application during heart valve surgery in the post-aprotinin era. One-hundred patients were enrolled in the study and all the patients were given tranexamic acid intravenously. The participants were randomized into two groups (A, n = 49; B, n = 51), and before commencing the sternal suturing, the study solution (group A: 250 ml of normal saline + tranexamic acid 2.5 g, placebo group B: 250 ml of normal saline) was poured into the pericardial cavity. The cumulative blood loss (geometric means [95% confidence intervals]) 4 h after the surgery was 86.1 [56.1, 132.2] ml in group A, and 135.4 [94.3, 194.4] in group B, test for equality of geometric means P = 0.107, test for equality of variances P = 0.059. Eight hours after the surgery, the blood loss was 199.4 [153.4, 259.2] ml in group A, 261.7 [205.1, 334.0] ml in group B, P = 0.130 and P = 0.050, respectively. Twenty-four hours postoperatively the blood loss was 504.2 [436.0, 583.0] ml in group A, 569.7 [476.0, 681.7] ml in group B, P = 0.293 and P = 0.014, respectively. The proportion of patients transfused postoperatively by fresh frozen plasma differed significantly between the two study groups (group A: n = 21, group B: n = 36, P = 0.008). Our hypothesis is supported by a significant difference in the inter-group variance of blood loss and the proportion of patients requiring fresh frozen plasma; however evident differences in mean postoperative blood loss were not statistically significant.

Can Topical Application of Tranexamic Acid Reduce Blood Loss in Thoracic Surgery? A Prospective Randomised Double Blind Investigation

“…What is the correct and sufficient topical concentration of TA to be delivered is, in our opinion, still not clear. In the pericardial cavity some authors used 1 g of TA in 100 ml of normal saline solution, others used 2.5 g of TA in 250 ml of saline solution or 2 g of TA in 100 ml of saline solution with concordant results [9][10][11][12]. In our study we used a dose of 5 g of TA in 100 ml of saline solution.…”

“…Different peri-operative pharmacological protocols have therefore been applied to reduce coagulation defects and bleeding complications, in particular after cardiac surgery [1,2,8]. The systemic infusion of antifibrinolytics drugs has proved to be effective in reducing post-operative bleeding and transfusion requirements after different surgical procedures [8,9,12,13]. In 2001, Ali Bedirhan et al [13] published the results of a randomised double-blind study on the systemic administration of aprotinin to reduce post-operative bleeding and blood transfusion in thoracic surgery.…”

“…Increased mortality, thromboembolic events, seizure, acute renal failure, anaphylactic reactions, graft vessels occlusion and acute myocardial infarction have been documented [8,9,15]. In order to avoid or reduce these serious complications, various authors have studied the efficacy of the topical application of antifibrinolytic agents such as aprotinin and tranexamic acid [9][10][11][12]. In particular some interesting studies come from cardiac surgery.…”

Tranexamic acid: a clinical review

“…In addition, there was no increase in adverse events. Spegar et al [81] studied the augmentation of systemic TXA by topical application (2.5 g in 250 mL saline into pericardial cavity) in valvular surgery (n = 100) and found intergroup variance on blood loss and fresh frozen plasma but a non-significant decrease in the volume of blood loss in the augmented group. In contrast, Fawzy et al [66] in their RCT (n = 38) found a decrease in postoperative blood loss (−626 mL vs −1,040 mL) and platelet transfusion (median units 0 vs 2) using 1 g TXA in 100 mL saline into the pericardial cavity.…”

The early management of patients with multiple injuries

“…Tranexamic acid is an antifibrinolytic drug that has been used for many years in cardiac surgery 30,31 and, more recently, in spinal surgery 32,33 and elective joint replacement to reduce intra-operative bleeding. 34,35 The recent CRASH-2 study randomised 20 211 patients with blunt or penetrating trauma who presented with a tachycardia (pulse > 110) or hypotension (sBP < 110) to receive tranexamic acid.…”