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

• Status: Completed
• Trial end date: 2017-05-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborator: Mayo Clinic
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

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