Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

NCT06832878 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-008865
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.

Conditions

Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Visual Analog Score

  The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

  Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

• Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)

  The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.

  Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Secondary Outcomes (5)

• Hemoglobin

  Baseline, prior to discharge, day 3 postoperatively

• Harris Hip Score (HHS)

  Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

• Short Form Health Survey (SF-12)

  Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

• Time to Independent Ambulation

  12 weeks

• Oxford Hip Score

  Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Study Arms (2)

Oral tranexamic acid

EXPERIMENTAL

Drug: Oral Tranexamic Acid

Control Group

NO INTERVENTION

Interventions

Oral Tranexamic Acid DRUG

Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3

Oral tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \> 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
• Written informed consent
• Patients undergoing primary THA diagnosis of end-stage osteoarthritis
• Patients receiving spinal anesthesia
• Patients being discharged on postoperative day 1

You may not qualify if:

• Patients with a TXA allergy
• Patients undergoing revision procedures
• Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
• Patients receiving general anesthesia
• Patients being discharged on the same day of surgery
• Cancer patients
• Patients with a history of prior VTE event
• Patients on preoperative anticoagulants other than ASA
• Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
• Female patients who are on hormonal contraception
• Patients with history of retinal vein or artery occlusion

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

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

Study Officials

• Joshua Bingham

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedics, Orthopedic Consultant

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)