NCT06902714

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
55mo left

Started Apr 2026

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2030

First Submitted

Initial submission to the registry

March 18, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 18, 2025

Last Update Submit

April 22, 2026

Conditions

Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • VAS

    visual analog scale

    2 weeks

Study Arms (2)

oral tranexamic acid

EXPERIMENTAL
Drug: oral tranexamic acid

Oral Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

oral tranexamic acidDRUG

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

oral tranexamic acid
PlaceboDRUG

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

Oral Placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Walter Smith, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Smith

CONTACT

205-930-8554waltersmith@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 30, 2025

Study Start

April 20, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(1)