Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Our purpose of this study therefore is to conduct a prospective randomized controlled trial
      to investigate the blood-conservation effect of combined topical application of these two
      hemostatic agents in different time during surgery and the safety compared with single
      topical application of TKA in a primary TKA procedure
    

Detailed description: 
      Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs
      for allogenic blood transfusion. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was
      reportedly effective reducing blood loss after standard TKA. Our 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%. There were some reports
      demonstrating the cost-effectiveness of topical application of TXA in TKA patients.

      Besides, thrombin-based hemostatic agents, Floseal®(Baxter, Deerfield, Illinois), have been
      widely used in surgical procedure. Some recent studies demonstrated that topical use of
      Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after
      TKA. But other studies showed Floseal® does not reduce blood loss in TKA procedures.

      We believe the topical use of hemostatic agent in patients with high risk of thromboembolism
      can avoid its systematic effect and decrease its potential perioperative risk of
      thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary
      embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical
      application of TXA in TKA patients. The blood saving effect of topical application of TXA in
      primary TKA was similar with systemic administration. The mean total blood loss of topical
      route of TXA inTKA patients was 940-1295 ml in different reports which was still high for
      patients with high thromboembolic risks. However, the efficacy and safety of topical use of
      TXA in TKA patients with history of thromboembolic disease is still unclear. A more effective
      regimen for bleeding prophylaxis afer primary TKA is necessary.

      We believe that combined topical applications of two hemostatic agents of different
      mechanisms can bring a synergistic effect in blood saving and does not increase the risk of
      thromboembolic disease after TKA.

      Our purpose of this study therefore is to conduct a prospective randomized controlled trial
      to investigate the blood-conservation effect of combined topical application of these two
      hemostatic agents in different time during surgery and the safety compared with single
      topical application of TKA in a primary TKA procedure.
    

Intervention name(s): Topical tranexamic acid; Floseal®; rivaroxaban (10mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule; Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter); Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other intervention name(s): Topical transamine; Thrombin-gelatin matrix; Xarelto
Intervention MeSH terms: Tranylcypromine; Rivaroxaban; Tranexamic Acid; Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Thrombin-gelatin matrix; Floseal; Tranexamic Acid; Total Knee Arthroplasty