Tranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty

NCT06208267 | Recruiting

• 1 other identifier: 2024-1082
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Step counts at 24 and 48 hours post -operative

  We hypothesize that patients receiving additional doses of TXA will mobilize more at 24 and 48 hours post- operatively and that this will be dose-dependent.

  Post-operative

Secondary Outcomes (11)

• Range of motion (ROM) of the hip (if applicable):

  4 - 6 weeks post op

• Range of motion (ROM) of the knee (if applicable):

  4 - 6 weeks post op

• Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total hip arthroplasty utilizing the Oxford Hip Score (OHS):

  4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively

• Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total knee arthroplasty utilizing the Oxford Knee Score (OKS):

  4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively

• Bleeding Complications requiring intervention

  Return to the emergency room or bleeding complications will be noted.

Study Arms (3)

1)Standard care: 1G TXA IV

ACTIVE COMPARATOR

1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure

Drug: Tranexamic acid

2) Standard + 1G oral TXA - 0 and 8 hours post-operatively

ACTIVE COMPARATOR

Standard + 1G oral TXA given at 0 and 8 hours post-operatively

Drug: Tranexamic acid

3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively

ACTIVE COMPARATOR

Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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

Also known as: CYKLOKAPRON

1)Standard care: 1G TXA IV; 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively; 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Mary's Research Center, Canada: lead

Study Sites (1)

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jennifer Mutch, MDCM, FRCSC

  St. Mary's Hospital Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Mutch, MDCM, FRCSC

CONTACT

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

Sandhya Baskaran, MBA, M.ED

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be recruited in the pre-operative clinic for surgery and randomized once all paperwork is completed. This randomization will be completed by a research assistant and transmitted to pharmacy to allow for the delivery of the proper medication packet. Neither the patient nor the treating physician will be made aware of the group to which the patient has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedic Research, Orthopaedic Surgeon

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: January 17, 2024
• Study Start: August 20, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)