The Blood Saving Effect of Tranexamic Acid in Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to conduct a prospective, randomized, double-blind study and assess
      the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty
      patients when tranexamic acid is used for bleeding prophylaxis.
    

Detailed description: 
      Total knee arthroplasty is an effective procedure for end-stage arthritis of the knee in
      terms of pain relief and functional recovery. However, this procedure is associated with a
      substantial perioperative blood loss. As high as 69% allogeneic blood transfusion rate was
      reported in patients receiving total knee arthroplasty when preoperative haemoglabin level
      was <13 g/dl. Tranexamic acid (TXA), an antifibrinolytic, given intraoperatively, has been
      reported to be effective in reducing one third of postoperative blood loss in standard total
      knee arthroplasty. Our previous study showed that TXA reduced total blood loss from 1453mL to
      833mL (p<0.001) and the need for transfusion from 20% to 4% (p=0.014) in total knee patients
      with enoxaparin (Clexane; Glaxo-Smith-Kline, Brentford, United Kindom) for
      thromboprophylaxis.

      In recent years, there have been more effective and practical methods for thrombophylaxis in
      total hip and knee replacement surgeries. Rivaroxaban is one of the first oral factor Xa
      inhibitors licensed for this regard. The advantages of rivaroxaban include oral
      administration, no need to monitor blood levels and no dosing adjustments which are
      convenient for short hospital stay in contemporary total knee arthroplasty. Its efficacy in
      preventing venous thromboembolism (VTE) after total knee arthroplasty have been extensitvely
      investigated in RECORD (Regulation of Coagulation in Orthopaedic surgery to prevent Deep-vein
      thrombosis and pulmonary embolism) 3 and 4 studies, and the results showed that rivaroxaban
      10mg once daily was superior to enoxaparin 40mg subcutaneously once daily or 30mg every 12
      hours for 10 to 14 days. Despite of its clinical efficacy in VTE prophylaxis, orthopaedic
      surgeons are still sceptic in routine use of rivaroxaban in knee and hip surgery and
      concerned about the increased risk of bleeding complications. A higher reoperation rate
      regarding wound complications within 30 days of hip and knee replacement in the rivaroxaban
      group than the tinzaparin group (2.94% versus 1.8%) was reported recently. Similar event has
      been reported in other studies. However, all these studies did not use TXA as bleeding
      prophylaxis after hip and knee replacement surgery. The risk of increasing VTE by use of TXA,
      owing to its antifibrinolytic effects, is the cause of concern.

      The aim of this study was to conduct a prospective, randomized, double-blind study and assess
      the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty
      patients when TXA is used for bleeding prophylaxis.
    

Intervention name(s): Tranexamic Acid 5%,5ml/amp (intraoperative); Tranexamic Acid 5%,5ml/amp (3 hours after operation); 0.9% Normal Saline (intraoperative); 0.9% Normal Saline (3 hours after operation); rivaroxaban (10mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tranexamic acid 1g administered intravenously five minutes before deflation of the tourniquet; tranexamic acid 1g administered intravenously 3 hours after operation; 0.9% Normal Saline 20ml administered intravenously five minutes before deflation of the tourniquet; 0.9% Normal Saline 20ml administered intravenously 3 hours after operation; Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14
Other intervention name(s): Transamine; Transamine; 0.9% sodium chloride; 0.9% Normal Saline; Xarelto
Intervention MeSH terms: Tranylcypromine; Rivaroxaban; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tranexamic Acid; Total Knee Arthroplasty; Rivaroxaban