Recruiting
Phase 3

Tranexamic Acid

Sponsor:

University of Alabama at Birmingham

Code:

NCT06902714

Conditions

Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

oral tranexamic acid

Placebo

Study Details

Brief summary:

The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid

Conditions

Shoulder Arthroplasty

Study ID

NCT06902714

Start date

Apr 20, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Skeletally mature patients (ages 18-79) undergoing primary total shoulder arthroplasty

Exclusion Criteria:

  • Patients with Cancer, venous thromboembolism, stroke, heart disease, pregnant or nursing, allergic to TXA, current tobacco use, anticoagulants other than aspirin.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: oral tranexamic acid

placebo comparator: Oral Placebo

Interventions

oral tranexamic acid

one group of subjects will receive oral tranexamic acid and the other will receive oral placebo

Placebo

one group of randomized subjects will receive placebo and the other will receive oral tranexamic acid

Primary outcome measure

  • VAS [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Walter Smith

205-930-8554waltersmith@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Walter Smith

205-930-8554waltersmith@uabmc.edu

Principal Investigator:

Walter Smith, MD

More Information

Sponsor

University of Alabama at Birmingham

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 University of Alabama at Birmingham on 2026-04-28.