Effect of Two Different Tranexamic Acid Doses on Blood Loss in Head and Neck Cancer Surgery: A Randomized, Double-Blind, Controlled Study.

Abstract

Background and aimHead and neck cancer is frequent, and surgeries pose more significant morbidity and mortality due to multitudinal causes; heavy blood loss and transfusion are among them. Tranexamic acid (TXA) is known to stabilize the micro clots hence controlling excessive blood loss. The present study aimed to compare perioperative blood loss with two different doses of TXA and placebo to find the effectiveness and optimal dose.MethodsWith ethical approvals and informed consent, the present prospective, randomized, double-blind, controlled study was conducted in a teaching institute from May 31, 2018, to Dec 28, 2019. Patients undergoing elective head and neck cancer (HNC) surgeries were included. Preoperative Hb < 7 gm% or > 16 gm%, known coagulopathy, anticoagulant therapy, contraindications to TXA, intraoperative torrential or blood loss due to arterial injury were excluded. Group T-1 received TXA 10mg/kg, T-II received 15 mg/kg, while the control group (Gr-C) received equal volume normal saline. Data about demography, surgical time, intraoperative and postoperative blood loss, and transfusion were collected and compared. SPSS software was used for analysis; p-value <0.05 was considered significant.ResultsNinety patients were screened, 84 completed the study. All three groups were similar in demographics. The median blood loss with 25th -75th percentile in group C, T-I, and T-II groups were 762.5 (513.5-1193), 541.5 (296.5-787), and 536.0 (180.5 - 879) mL, respectively; p: 0.025. There was a significant difference between the control group and T-I (p-value: 0.0153), and control and T-II (p-value: 0.0248), but an insignificant difference between T-I and T-II (p-value: 0.706). 5 (17.85%) in each of T-I and T-II required transfusion, whereas 14 (50%) in the control group required it; p < 0.011). No major clinically significant related to study drugs were noted.ConclusionCompared to placebo (normal saline), preoperative administration of TXA in bolus significantly reduced perioperative blood losses and transfusion requirement in patients undergoing HNC surgery as estimated using the Hb-based method. A bolus dose of doses of 10mg/kg and 15 mg/kg is equally effective.