Actively Recruiting
Evaluating the Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty: A Randomized Control Trial
Led by University of Alabama at Birmingham · Updated on 2026-04-28
60
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on patients aged 18 to 79 undergoing primary total shoulder arthroplasty. Researchers are evaluating the short-term clinical outcomes after surgery when patients receive an extended course of oral tranexamic acid. The study is a randomized, triple-blind, phase 3 trial sponsored by the University of Alabama at Birmingham, aiming to assess the effects of this drug compared to a placebo. Participants will be randomly assigned to one of two groups: one will receive oral tranexamic acid, and the other will receive an oral placebo. Both treatments are given after surgery to study how they affect recovery over the short term. The study is designed to compare these two oral treatments in patients undergoing shoulder replacement surgery. During the study, participants will be monitored for pain and other clinical outcomes over a two-week period, with pain assessed using a visual analog scale (VAS). The study team will track these outcomes to understand the impact of the medication on postoperative recovery. The total participation duration includes this short-term follow-up, with safety and effectiveness evaluated during this time.
CONDITIONS
Brief Title
Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Skeletally mature patients (ages 18-79) undergoing primary total shoulder arthroplasty
You will not qualify if you...
- Patients with cancer
- Patients with venous thromboembolism
- Patients with stroke
- Patients with heart disease
- Pregnant or nursing patients
- Patients allergic to tranexamic acid
- Current tobacco users
- Patients taking anticoagulants other than aspirin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Short term postoperative period
Participants receive either oral tranexamic acid or a placebo following their total shoulder arthroplasty surgery.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
Research Team
W
Walter Smith
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here