Recruiting

Tranexamic Acid

Sponsor:

St. Mary's Research Center, Canada

Code:

NCT06208267

Conditions

Postoperative Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic acid

Study Details

Brief 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.

Conditions

Postoperative Bleeding

Study ID

NCT06208267

Start date

Aug 20, 2025

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • Known hypersensitivity or allergy to TXA
  • Previous history of thromboembolic disease
  • Active malignancy (all current cancers other than local skin cancer)
  • Significant renal disease (hematuria, dialysis, kidney transplant)
  • History of convulsions
  • Known defective colour vision
  • Inability or unwillingness to use MyMobility app
  • Unable to communicate in French or English

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Tranexamic acid

This is a 3 arm RCT using the three dosage regimens mentioned above. Placebo doses will be provided for the 0, 8, 16 and 24 hours without TXA

Primary outcome measure

  • Step counts at 24 and 48 hours post -operative [ Time Frame: Post-operative ]

Central Contacts and Locations

Central contacts

Jennifer Mutch, MDCM, FRCSC

514 345 3511j.mutch.ortho@gmail.com

Sandhya Baskaran, MBA, M.ED

514 239 0042sandhya.baskaran.comtl@ssss.gouv.qc.ca

Locations

St. Mary's Hospital Center

Recruiting

Montreal, Quebec, Canada, H3T 1M5

Contacts

Jennifer Mutch, MDCM, FRCSC

514 345 3511j.mutch.ortho@gmail.com

Sandhya Baskaran, MBA, M.ED

514 239 0042sandhya.baskaran.comtl@ssss.gouv.qc.ca

Principal Investigator:

Jennifer Mutch, MD FRCP

More Information

Sponsor

St. Mary's Research Center, Canada

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Mary's Research Center, Canada on 2026-04-28.