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

PHASE4CompletedINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

December 28, 2015

Study Completion Date

May 16, 2017

Conditions
Osteoarthritis
Interventions
DRUG

Topical Tranexamic Acid

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.

DRUG

Intravenous Tranexamic Acid

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Trial Locations (2)

10021

Hospital for Special Surgery, New York

55902

Mayo Clinic, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mayo Clinic

OTHER

lead

Hospital for Special Surgery, New York

OTHER

NCT01940523 - Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical | Biotech Hunter | Biotech Hunter