Abstract

BACKGROUND The efficacy of a thrombin-based hemostatic agent (Floseal®) on reducing postoperative blood loss after total knee arthroplasty (TKA) was still unclear. The aim of our study was to conduct a prospective randomized controlled study to compare the blood conservation effects of Floseal® and topical TXA in patients with preexisting thromboembolic risk undergoing primary minimally invasive TKA. METHODS Our power analysis of this study was based upon the following description, to obtain a statistical power of 0.90 and an alpha error of 0.05, 30 patients were required in each group. Therefore, we enrolled a total of 103 patients with at least one of the risk factors for thromboembolism who underwent unilateral primary minimally invasive TKA, and the participants were randomly divided into the topical TXA group (n = 34), receiving intra-articular injection of 3 g of TXA in 100 mL saline after TKA, the topical Floseal® group (n = 34), receiving 10 mL of Floseal® intra-articularily during surgery, and the placebo group (n = 35), receiving an intra-articular saline injection only. The total blood loss (TBL) and hemoglobin (Hb) drop were compared among the 3 groups. RESULTS The TXA group had a lower TBL of 645 mL (227 to 1090) in comparison with 1145 mL (535 to 1942) in the Floseal® group and 1103 mL (424 to 1711) in the placebo (p < 0.001, respectively). The TBL was similar between the Floseal® group and the placebo group (p = 0.819). No patients in any group had symptoms of venous thromboemblism. CONCLUSION Our prospective randomized controlled study showed that intra-articular application of TXA was superior to hemostatic matrix (Floseal®) in terms of blood conservation in patients with preexisting thromboembolic risk undergoing minimally invasive TKA. This trial is registered with Clinicaltrials.gov (NCT02865174) on 08/09/2016.

Abstract

BACKGROUND Tranexamic acid (TXA) was reportedly to decrease postoperative blood loss after standard total knee arthroplasty (TKA). However, the blood-conservation effect of TXA in minimally invasive TKA, in particular, receiving a direct oral anticoagulant was unclear. The aim of the study was to investigate the efficacy of combined use of TXA and rivaroxaban on postoperative blood loss in primary minimally invasive TKA. METHODS In a prospective, randomized, controlled trial, 198 patients were assigned to placebo (98 patients, normal saline injection) and study group (100 patients, 1g TXA intraoperative injection) during primary unilateral minimally invasive TKA. All patients received rivaroxaban 10 mg each day for 14 doses postoperatively. Total blood loss was calculated from the maximum hemoglobin drop after surgery plus amount of transfusion. The transfusion rate and wound complications were recorded in all patients. Deep-vein thrombosis was detected by ascending venography of the leg 15 days postoperatively. RESULTS The mean total blood loss was lower in the study group (1020 mL [95% confidence interval, 960-1080 mL]) compared with placebo (1202 mL [95% confidence interval, 1137-1268 mL]) (P < .001). The transfusion rate was lower in the study group compared with placebo (1% vs 8.2%, P = .018). Postoperative wound hematoma and ecchymosis were higher in placebo than the study group (P = .003). There was no symptomatic deep-vein thrombosis or pulmonary embolism in either group. CONCLUSION Systemic administration of TXA can effectively reduce the postoperative blood loss which results in lower rate of transfusion requirement and wound hematoma in minimally invasive TKA patients when rivaroxaban is used for thromboprophylaxis. Rivaroxaban has a high rate of bleeding complications when used alone in TKA patients.