Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty

NCT ID: NCT06902714

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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oral tranexamic acid

Group Type EXPERIMENTAL

oral tranexamic acid

Intervention Type DRUG

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

Oral Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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oral tranexamic acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Walter Smith

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walter Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Walter Smith

Role: CONTACT

205-930-8554

Facility Contacts

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Walter Smith

Role: primary

205-930-8554

Other Identifiers

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UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300014204

Identifier Type: -

Identifier Source: org_study_id

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