Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Intravenous tranexamic acid; Topical tranexamic acid; Intravenous saline; Topical saline
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Total Knee Arthroplasty; Total Knee Replacement

Summary:

      Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for
      Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is
      an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA
      can be given either intravenously or topically (placed directly on the open wound) before
      wound closure. Patients with certain medical conditions have been found to have a high risk
      of thrombosis after being given intravenous TXA, which may lead to serious complications.
      However, to date, no high-risk patients have been identified for use of topical TXA. This
      study will look at thrombogenic markers (proteins found in blood that promote clot formation)
      after TXA is given either intravenously or topically. If the effect on these markers is
      similar between intravenous and topical use of TXA, then the safety of topical TXA should be
      questioned. Of note, these markers have never been measured after TXA has been given
      topically. As a result, this information would be important for the medical community.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary unilateral total knee replacement with a participating
             surgeon

          -  Patients aged 18-80

        Exclusion Criteria:

          -  All patients on steroid therapy regardless of dose, duration, or treatment or those
             requiring stress-dose steroids preoperatively

          -  Patients who will require postoperative use of Coumadin, Xarelto, or Plavix

          -  Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery

          -  Hypersensitivity to tranexamic acid

          -  Renal dysfunction (Creatinine clearance < 40 ml/min)

          -  Hepatic dysfunction (AST or ALT 2x upper limit of normal)

          -  Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress
             test, atrial fibrillation, advanced coronary artery disease

          -  Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease

          -  History of venous thromboembolism

          -  Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or
             without prior venous thromboembolism)

          -  History of stroke or transient ischemic attack