The Efficacy and Safety of Postoperative Tranexamic Acid, Hemocoagulase Agkistrodon, and their Combination in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass

Background Excessive bleeding is a major complication in patients undergoing cardiac surgery. We aimed to compare the efficacy and safety of postoperative tranexamic acid (TXA), hemocoagulase agkistrodon and their combination in patients undergoing heart valve replacement surgery with cardiopulmonary bypass (CPB). Methods This was a retrospective study. The enrolled patients were intravenously injected with TXA at a dose of 1.0 g during the intraoperative period. After surgery, the patients were assigned to four groups: the control group (Group C), the TXA group (Group T), the hemocoagulase agkistrodon group (Group H) and the combination group (Group TH). The primary efficacy outcomes were the total blood loss (TBL) from the time of the operation to postoperative Day 2, postoperative blood loss within 2 days, and transfusion of red blood cells and plasma from the operation to postoperative Day 3. The primary safety endpoint was the incidence of thromboembolic events. Results A total of 252 patients were recruited. There were no statistically significant differences in terms of the TBL, postoperative blood loss, volumes of red blood cells or plasma transfusion among the four groups. However, an increased total pericardial drainage volume and longer length of stay in the ICU were found in Group H compared with in Group T. In addition, increased volumes of total pericardial drainage were found in Group TH compared with Groups C and T. A similar result was also found in the number of days of pericardial drainage. Regarding safety outcomes, fibrinogen levels on postoperative Days 1 and 2 in Groups H and TH were significantly lower than those in Groups C and T, while the frequencies of human fibrinogen transfusion in Groups H and TH were higher, with the highest frequency in Group H. The transfusions of human fibrinogen among Groups C, T, H and TH were 1.45%, 2.78%, 64.71%, and 28.72%, respectively. No significant differences were found in the postoperative incidences of thromboembolic events and acute kidney injuries among all groups. Conclusions Bleeding events after cardiac valve replacement surgery with CPB were not improved by postoperative administration of TXA, hemocoagulase agkistrodon or their combination. Hemocoagulase agkistrodon is related to hypofibrinogenemia and increased transfusions of human fibrinogen.