Evaluating the Efficacy and Safety of a Single-Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy: A Randomized Comparative Pilot Study

Abstract

Background: Hyperthermic intraperitoneal chemotherapy (HIPEC), following cytoreductive surgery (CRS), is a lengthy procedure, usually associated with considerable bleeding due to the extensive nature of surgery. Various techniques have been used to decrease blood transfusion requirements. Objectives: This study aimed to evaluate the possible advantage of a single dose of tranexamic acid (TA) in such surgeries. Methods: In this randomized comparative pilot study, 60 patients scheduled to undergo CRS followed by HIPEC were randomly assigned to 2 equal groups: group 1 (TA group) that received 10 mg/kg of TA in 100 mL of 0.9% NaCl over 20 minutes after the induction of anesthesia and before surgical incision, and group 2 (control group) that received a placebo of 100 mL of 0.9% NaCl during the same time interval. The primary endpoint was the blood loss volume. The secondary endpoints were the number of patients requiring transfusion and the occurrence of any postoperative thrombotic events 30 days after surgery. Serum creatinine levels were measured before the operation and on postoperative days 1, 3, and 5. Intraoperative and first 24 hours urine outputs were also recorded. The levels of hemoglobin (Hb) were measured before the operation, immediately after the operation, and 5 days postoperatively. Results: Compared to the control group, the TA group exhibited lower intraoperative blood loss, as well as lower blood loss on postoperative day 1 and in total blood loss (P = 0.006, 0.035, and 0.001, respectively). However, the blood loss on the remaining postoperative days was comparable between both groups. Intraoperative blood transfusion requirements were lower in the TA group (P = 0.032) than in the control group. The total number of units of blood and plasma transfused was also lower in the TA group both intra and postoperatively (0.007, 0.40, and 0.032, 0.008, respectively) than in the control group. Hemoglobin levels, serum creatinine levels, and urine outputs during the first 24 hours postoperatively were comparable between the 2 groups. The thromboembolic events within 30 days were also comparable between the 2 groups. Conclusions: Administering a single dose of TA between the induction of anesthesia and the surgical incision may reduce blood loss and transfusion rates in CRS followed by HIPEC without causing significant adverse effects. It is a promising approach in surgeries where massive blood loss is expected shortly after anesthesia induction. This can minimize the drawbacks of repeated blood transfusions during and after the operation without causing significant adverse effects. Besides reducing the need for repeated blood transfusions, it would also reduce the costs of blood/blood products and the risks of transfusion.