Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Topical tranexamic acid; Floseal®; rivaroxaban (10mg)
Intervention description: 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.
Intervention MeSH terms: Tranylcypromine; Rivaroxaban; Tranexamic Acid; Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Thrombin-gelatin matrix; Floseal; Tranexamic Acid; Total Knee Arthroplasty

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who have advanced knee osteoarthritis are scheduled to undergo primary,
             unilateral elective total knee replacement surgery

          2. Age > 50 years and < 90 years

          3. Failure of medical treatment or rehabilitation.

          4. Hemoglobin > 11g/dl,

          5. No use of non-steroid anti-inflammatory agent one week before operation

        Exclusion Criteria:

          1. Preoperative Hemoglobin ≦11 g/dl

          2. History of infection or intraarticular fracture of the affective knee

          3. Renal function deficiency (GFR <30 ml/min/1.73m2)which is relative contraindicated for
             chemical venous thromboembolism

          4. Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of
             liver cirrhosis, impaired liver function(elevated total bilirubin level) and
             coagulopathy (including long-term use anticoagulant)

          5. History of deep vein thrombosis, ischemic heart disease or stroke

          6. Contraindications of tranexamic acid, floseal, or rivaroxaban

          7. Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients

          8. History of heparin-induced thrombocytopenia (HIT)

          9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone
             marrow suppression etc.

         10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI
             bleeding, hematuria.

         11. Patients with known allergies to materials of bovine origin