Osteoarthritis, Knee Clinical Trial
Official title:
Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty
The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study
Investigators previous experiences in minimally invasive (MIS) TKA showed that
intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for
transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use
TXA systemically in TKAs especially in high risk patients with a potential increase in
thromboembolic events following surgery.
Because of this concern, recently, there were few reports demonstrating the
cost-effectiveness of topical application of TXA in TKA patients. However, most of the
reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA.
Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial
are demonstrated similar transfusion rate and perioperative blood loss between topical
administration and intravenous injection of TXA in TKA patients. There were no significant
safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for
thromboembolism prophylaxis in that study.
Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care
after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in
TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by
rivaroxaban, an increased postoperative bleeding has been reported. There have been little
studies investigating the blood-conservation effect of TXA on TKA patients either by
infusion or by topical application when rivaroxaban used as VTE prophylaxis.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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