Extra oral tranexamic acid after hip or knee replacement to reduce bleeding and improve pain and mobility
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
This study will test whether giving extra oral tranexamic acid after primary hip or knee replacement helps reduce visible bleeding and improves pain, mobility, and function in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Mary's Research Center, Canada Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06208267 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing the current intraoperative IV tranexamic acid regimen to the same regimen plus additional oral tranexamic acid doses given after primary total hip or knee arthroplasty. Outcomes include visible bleeding on dressings, activity and steps measured via the MyMobility app, pain on a visual analog scale, joint function using the Oxford hip and knee scores, and range of motion at four to six weeks. Adults having primary THA or TKA at St. Mary's Hospital Center who meet eligibility will be enrolled, with exclusions for prior thromboembolic disease, significant renal disease, seizures, active cancer, TXA allergy, color vision defect, or inability to use the app or speak English/French. Follow-up is conducted locally with app-based activity tracking and clinical assessments at the postoperative visit.
Who should consider this trial
Good fit: Adults undergoing primary total hip or knee arthroplasty at St. Mary's Hospital who can use the MyMobility app and do not have TXA allergy, thromboembolic history, significant renal disease, seizure disorder, active cancer, or defective color vision.
Not a fit: Patients with prior thromboembolic disease, significant renal impairment, seizure history, active cancer, known TXA allergy, those unable to use the MyMobility app, or who cannot communicate in English or French are excluded and would not be eligible to receive any potential benefit from participation.
Why it matters
Potential benefit: If successful, adding postoperative oral TXA could reduce bleeding and pain and help patients regain mobility faster after hip or knee replacement.
How similar studies have performed: Numerous randomized trials and observational studies have shown TXA reduces blood loss and transfusion in orthopedic surgery, but the added value of extra postoperative oral dosing for improving pain and mobility is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec
- St. Mary's Hospital Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Jennifer Mutch, MDCM, FRCSC — St. Mary's Hospital Centre
- Study coordinator: Jennifer Mutch, MDCM, FRCSC
- Email: j.mutch.ortho@gmail.com
- Phone: 514 345 3511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.