Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

• Primary intra-operative blood loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Record intra-operative blood loss through drain output and number of dressing changes, number of transfusions, as well as changes in hemoglobin and hematocrit levels.
  
  
• Document incidences of DVT and other thromboembolic events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  

• Secondary Outcomes post-operative swelling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Determine post-operative swelling by measuring thigh and leg circumference pre-operatively and post-operatively on day 1 and day 2, as well as at 2 week, 6 week, and 3 month follow-up.
  
  
• Evaluate range of motion at discharge, as well as at 2 week, 6 week, and 3 month follow-up [ Time Frame: discharge, week 2, week 6, 3 month followup ] [ Designated as safety issue: No ]
  

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) with each group split evenly between males and females. 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.