Topical Tranexamic Acid for Total Knee Arthroplasty

PHASE4CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2009

Conditions
Surgical Blood LossTotal Knee Arthroplasty
Interventions
DRUG

tranexamic acid

"Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo).~The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues."

DRUG

Placebo

"Patients will receive a solution containing either 1.5g or 3 g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) or only 50 ml of saline without TA (placebo).~The treatment solution will be prepared under sterile conditions and coded at TWH pharmacy. In the OR the sterile bag containing the solution will be given to the scrub nurse. The contents (50 ml) will be emptied in a sterile surgical bowl. TA or placebo solution (50 ml) will be then applied to the open joint and tissues by the bulb syringe and will be left in contact with the tissues for 5 minutes. Excess solution will be subsequently suctioned by placing the suction tip on the cemented component without touching the joint and surrounding tissues."

Trial Locations (1)

M5T 2S8

Toronto Western Hospital, Toronto

All Listed Sponsors
collaborator

The Physicians' Services Incorporated Foundation

OTHER

lead

University Health Network, Toronto

OTHER

NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty | Biotech Hunter | Biotech Hunter