Oral tranexamic acid after total shoulder replacement to reduce bleeding and help early recovery.
Evaluating the Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty: A Randomized Control Trial
This Phase 3 study will test whether taking oral tranexamic acid after a total shoulder replacement helps adults 18–79 have less bleeding and better short-term recovery compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06902714 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study at the University of Alabama at Birmingham gives patients undergoing primary total shoulder arthroplasty an extended postoperative course of either oral tranexamic acid or a matching placebo. Participants are skeletally mature adults aged 18–79 and those with active cancer, prior venous thromboembolism or stroke, significant heart disease, pregnancy or nursing, TXA allergy, current tobacco use, or use of anticoagulants other than aspirin are excluded. The trial focuses on short-term postoperative clinical outcomes, including measures related to bleeding, hemoglobin, wound complications, and early functional recovery. Results will show whether an extended oral TXA regimen improves early recovery after shoulder replacement compared with placebo.
Who should consider this trial
Good fit: Adults aged 18–79 having a primary total shoulder replacement who do not have active cancer, recent clotting or stroke history, significant heart disease, pregnancy or breastfeeding, allergy to TXA, current tobacco use, or use of anticoagulants other than aspirin are appropriate candidates.
Not a fit: Patients with a history of venous thromboembolism, recent stroke, significant cardiac disease, active cancer, pregnancy or nursing, TXA allergy, current tobacco use, or who take anticoagulants other than aspirin are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, taking oral tranexamic acid after shoulder replacement could reduce postoperative bleeding and speed early recovery.
How similar studies have performed: Previous work in hip and knee arthroplasty and some shoulder procedures has shown that tranexamic acid can reduce blood loss and transfusion needs, but extended postoperative oral regimens after shoulder replacement are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Walter Smith, MD — University of Alabama at Birmingham
- Study coordinator: Walter Smith
- Email: waltersmith@uabmc.edu
- Phone: 205-930-8554
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.