Multiple-Dose Intravenous Tranexamic Acid in Total Knee Arthroplasty in Patients with Rheumatoid Arthritis: A Randomized Controlled Study

Abstract Background: To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who underwent primary unilateral total knee arthroplasty (TKA).Methods: In this single-center, single-blind randomized controlled clinical trial, ten male and 87 female participants aged 50–75 years, with RA who underwent unilateral primary TKA were randomly assigned (1:1) to receive a single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total red blood cell loss (TBL), hidden red blood loss (HBL) and maximum hemoglobin (Hb) drop. Secondary outcomes were transfusion rate and levels of D-dimer. All parameters were measured post-operatively during inpatient hospital stay.Results: Between September 2019 and May 2020, 104 participants were randomized. 7 were lost follow-up. Mean TBL, HBL, and maximum Hb drop in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in groups A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. D-dimer level was lower in group B than in group A on post-operative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the two groups (P > 0.05). Conclusion: Three doses of post-operative IV-TXA could further reduced blood loss, maximum Hb drop, and diminished the postoperative fibrinolytic responses without increasing the risk of complications.Trial registration: The trial was registered in Chinese Clinical Trial Registry (ChiCTR1900025013).Name of the registry: Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty. Prospective registration, ChiCTR1900025013. Registered 7 August 2019, http://www.chictr.org.cn/showproj.aspx?proj=41375