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

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.

Inclusion Criteria:

1. Patients must be male or female of any race

2. Ages 18-80 years old

3. Patients must be undergoing an elective, primary knee arthroplasty

4. Patients must be able to understand and willing to cooperate with study procedures

5. Patients must be able to provide written and verbal informed consent

Exclusion Criteria:

1. Allergy or intolerance to the study materials

2. History of a venous thromboembolic event being treated with life-long anticoagulation

3. Patients with a known congenital thrombophilia

4. Patients who have had a venous thromboembolic event within the 12 months preceding
surgery

5. History of any substance abuse or dependence within the last 6 months

6. Failure in collecting a required data point during study

7. Those patients not indicated for knee replacement surgery including, pregnant women,
those not cleared medically for the procedure and patients without significant
radiographic evidence of degenerative joint disease.

8. Patient using autologous blood transfusion