Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
BioMed research international. 2021;2021:2549521
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.
Intravenous tranexamic acid use in revision total joint arthroplasty: a meta-analysis
Drug Design, Development and Therapy. 2018;12:3163-3170.
Purpose: Massive perioperative blood loss in complex revision total joint arthroplasty (TJA) often requires blood transfusions. Tranexamic acid (TXA) has been used in elective primary TJA to minimize blood loss and transfusions. The purpose of this meta-analysis was to evaluate the safety and efficacy of intravenous TXA in revision TJA. Methods: A literature search of PubMed, Scopus, and the Cochrane Controlled Trials Register was performed to identify studies published between January 2000 and May 2017. All randomized controlled trials (RCTs) and retrospective cohort observational studies evaluating the efficacy of intravenous TXA during revision total knee arthroplasty (TKA) and total hip arthroplasty (THA) were included. The mean differences (MDs) of blood loss, hemoglobin (Hb) change, and red blood cell (RBC) units transfused were compiled, and ORs of transfusion and venous thromboembolism (VTE) events in TXA and control groups were calculated. Results: Seven studies involving 930 patients were included (501 TXA vs 429 control). Intravenous TXA use had a significantly less blood transfusion (OR=0.20, 95% CI=0.11-0.34, P<0.001), lower Hb drop (MD=-0.88, 95% CI=-1.31 to -0.44, P<0.001), and less number of RBC units transfused (MD=-0.44, 95% CI=-0.65 to -0.24, P<0.001) compared to control in the postoperative period. No significant difference was seen in blood loss (MD=-245, 95% CI=-556 to 66, P=0.12) and VTE events (OR=0.57, 95% CI=0.13-2.42, P=0.45) between groups. Conclusion: Our meta-analysis suggests that intravenous administration of TXA can significantly reduce blood transfusion requirements following revision TJA, without increasing the risk of VTE. However, due to the variation in included studies, larger RCTs are required to draw firm conclusions.
The efficacy of combined use of rivaroxaban and tranexamic acid on blood conservation in minimally invasive total knee arthroplasty a double-blind randomized, controlled trial
The Journal of Arthroplasty. 2016;32((3):):801-806
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.
A regime of two intravenous injections of tranexamic acid reduces blood loss in minimally invasive total hip arthroplasty: a prospective randomised double-blind study
Bone & Joint Journal. 2015;97 B.C.((7)):905-10.
Tranexamic acid (TXA), an inhibitor of fibrinolysis, reduces blood loss after total knee arthroplasty. However, its effect on minimally invasive total hip arthroplasty (THA) is not clear. We performed a prospective, randomised double-blind study to evaluate the effect of two intravenous injections of TXA on blood loss in patients undergoing minimally invasive THA. In total, 60 patients (35 women and 25 men with a mean age of 58.1 years; 17 to 84) who underwent unilateral minimally invasive uncemented THA were randomly divided into the study group (30 patients, 20 women and ten men with a mean age of 56.5 years; 17 to 79) that received two intravenous injections 1 g of TXA pre- and post-operatively (TXA group), and a placebo group (30 patients, 15 women and 15 men with a mean age of 59.5 years; 23 to 84). We compared the peri-operative blood loss of the two groups. Actual blood loss was calculated from the maximum reduction in the level of haemoglobin. All patients were followed clinically for the presence of venous thromboembolism. The TXA group had a lower mean intra-operative blood loss of 441 ml (150 to 800) versus 615 ml (50 to 1580) in the placebo (p = 0.044), lower mean post-operative blood loss (285 ml (120 to 570) versus 392 ml (126 to 660) (p = 0.002), lower mean total blood loss (1070 ml (688 to 1478) versus 1337 ml (495 to 2238) (p = 0.004) and lower requirement for transfusion (p = 0.021). No patients in either group had symptoms of venous thromboembolism or wound complications. This prospective, randomised controlled study showed that a regimen of two intravenous injections of 1 g TXA is effective for blood conservation after minimally invasive THA. Cite this article: Bone Joint J 2015;97-B:905-10. Copyright ©2015 The British Editorial Society of Bone & Joint Surgery.
The blood-saving effect of tranexamic acid in minimally invasive total knee replacement: is an additional pre-operative injection effective?
Journal of Bone & Joint Surgery - British Volume. 2012;94((7):):932-6.
Tranexamic acid (TEA), an inhibitor of fibrinolysis, reduces blood loss after routine total knee replacement (TKR). However, controversy persists regarding the dosage and timing of administration of this drug during surgery. We performed a prospective randomised controlled study to examine the optimum blood-saving effect of TEA in minimally invasiveTKR. We randomly assigned 151 patients who underwent unilateral minimally invasive TKR to three groups: 1) a placebo group (50 patients); 2) a one-dose TEA group (52 patients), who received one injection of TEA (10 mg/kg) intra-operatively on deflation of the tourniquet; and 3) a two-dose TEA group (49 patients), who received two injections of TEA (10 mg/kg) given pre-operatively and intra-operatively. Total blood loss was calculated from the maximum loss of haemoglobin. All patients were followed clinically for the presence of venous thromboembolism (VTE). The mean total blood loss was significantly higher in the placebo group than in the other two groups (1222ml (845 to 2043) versus 1035ml (397 to 1934) and 986ml (542 to 1811), respectively (both p < 0.0001)). The mean blood loss was not significantly different between the one- and two-TEA groups (p = 0.148). The mean transfusion rate was higher in the placebo group than in the other two groups (22% versus 3.8% (p = 0.006) and 6.1% (p=0.041), respectively) and there was no statistically significant difference in the mean transfusion rate between the one- and two-TEA groups (p = 0.672). Only one patient, in the two-dose group, had a radiologically confirmed deep venous thrombosis. Our prospective randomised controlled study showed that one intra-operative injection of TEA is effective for blood conservation after minimally invasive TKR