Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Condition: Osteoarthritis; Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious
      than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This
      includes having a greater impact on decreasing blood loss without increasing the occurrence
      of adverse thromboembolic events in patients undergoing primary, elective total knee
      arthroplasty.

      Secondary - TA will decrease blood loss more effectively in women than in men undergoing this
      procedure.
    

Detailed description: 
      Overall Study Design

      Study design and control methods:

      This study is designed as a prospective, randomized, double-blinded controlled clinical trial
      to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose
      of tranexamic acid (TA).

      Treatment group:

      The subjects will be randomly assigned to the uniform dose group or weighted dose group at
      the time of the surgery via the opening of a randomly selected closed envelope. The patient
      and the independent reviewer will be blinded as to the dose of TA utilized during the
      surgery. This information will be linked to a confidential database for later review by the
      principal investigator.

      Treatment allocation:

      All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be
      treated and observed per the research protocol. All patients will maintain the right to
      refuse participation and receive a specific treatment of the study if desired.

      Trial Population

      Target population:

      The target sample size is 60 patients of each of the uniform and weighted dose groups (120
      total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to
      enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific
      diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the
      time of surgery. All 120 patients will be enrolled from the office of the primary
      investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the
      exclusion criteria is met.

      Results from randomized patients will be compared to a historical control arm that did not
      receive TA in their treatment.
    

Intervention name(s): Tranexamic Acid standard dose; Females Tranexamic Acid weighted dose; Females receiving a uniform dose of TA; Males Weighted Dose TA
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Uniform 1 gram dosing; Weighted dose--20mg/kg of the drug will be given; Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.; Weighted dose--20mg/kg of the drug will be given
Other intervention name(s): Male TA; TA; Tranexamic Acid; Transexamic Acid
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Blood loss; transfusion rates; complications