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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Tranexamic Acid

Criteria

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