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Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty

NCT06638749 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-10-15

No results posted yet for this study

Summary

Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that has been well studied and routinely used for hip and knee arthroplasty. In hip and knee arthroplasty, the use of tranexamic acid decreases blood loss and the need for transfusion without increasing the risk of thromboembolic events. Due to the increased use of reverse total shoulder arthroplasty in the treatment of shoulder pathology, there has been interest in making the procedure safer for patients. TXA is a promising drug which could be useful to surgeons as they seek to achieve this goal, however, it has not been extensively studied in this setting. The purpose of this prospective randomized, controlled study is to determine the effectiveness and safety of using tranexamic acid to decrease blood loss in reverse total shoulder arthroplasty.

Conditions

  • Shoulder Arthritis
  • Blood Loss, Surgical
  • Tranexamic Acid Adverse Reaction

Interventions

DRUG

Tranexamic Acid

Administration of tranexamic acid

DRUG

Normal Saline

Administration of normal saline

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-01
Completion
2024-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638749 on ClinicalTrials.gov