Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Topical Tranexamic Acid; Intravenous Tranexamic Acid
Intervention description: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.; 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 640.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: total knee arthroplasty; total knee replacement; tranexamic acid; osteoarthritis; degenerative joint disease

Summary:

      The purpose of this study is to determine whether topical or intravenous administration of
      tranexamic acid during unilateral total knee replacement is more effective at reducing
      bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that
      has been shown to reduce blood drain output and the need for blood transfusions in both its
      topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that
      IV and topical administration of tranexamic acid will be equally good at reducing the loss of
      blood and the need for transfusion immediately following total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary total knee replacmeent

          -  Osteoarthritis

          -  Unilateral

        Exclusion Criteria:

          -  Revision surgery

          -  Donated preoperative autologous blood

          -  On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin
             (other than 81mg)

          -  Preoperative hepatic or renal dysfunction

          -  Diagnosis of inflammatory disease

          -  Diagnosis of inflammatory arthritis

          -  Pregnant

          -  Breastfeeding

          -  Preoperative hemoglobin <10g/dL

          -  International Normalized Ratio>1.4

          -  Abnormal Partial Thromboplastin Time

          -  Preoperative platelet count of <150,000mm^3

          -  Creatinine > 1.4