Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision. The primary result measurement will be blood drain output from the knee at 24 hours after surgery.

Who is eligible to participate?

Inclusion Criteria: - Primary total knee replacmeent - Osteoarthritis - Unilateral Exclusion Criteria: - Revision surgery - Donated preoperative autologous blood - On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg) - Preoperative hepatic or renal dysfunction - Diagnosis of inflammatory disease - Diagnosis of inflammatory arthritis - Pregnant - Breastfeeding - Preoperative hemoglobin <10g/dL - International Normalized Ratio>1.4 - Abnormal Partial Thromboplastin Time - Preoperative platelet count of <150,000mm^3 - Creatinine > 1.4

Last updated:

5/28/2014

NCT ID:

NCT01940523

IRB Number:

12-009490