The Impact of Additional Post-operative Doses of Tranexamic Acid on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty. The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide. This RCT aims to compare the current standard dosing for TXA to additional TXA doses given orally post-operatively for THA and TKA patients. The goal is to compare the following between study groups: visible bleeding on post-operative dressing, mobilization (steps, amount of time moving around), pain (visual analog scale), function (Oxford hip and knee scales) and ROM at four to six weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• ° All adults undergoing primary TKA and THA at St-Mary's Hospital

Locations
Other Locations
Canada
St. Mary's Hospital Center
RECRUITING
Montreal
Contact Information
Primary
Jennifer Mutch, MDCM, FRCSC
j.mutch.ortho@gmail.com
514 345 3511
Backup
Sandhya Baskaran, MBA, M.ED
sandhya.baskaran.comtl@ssss.gouv.qc.ca
514 239 0042
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2027-04
Participants
Target number of participants: 210
Treatments
Active_comparator: 1)Standard care: 1G TXA IV
1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure
Active_comparator: 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively
Standard + 1G oral TXA given at 0 and 8 hours post-operatively
Active_comparator: 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively
Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively
Related Therapeutic Areas
Sponsors
Leads: St. Mary's Research Center, Canada

This content was sourced from clinicaltrials.gov