Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

NCT04594408 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-04-02

No results posted yet for this study

Summary

The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.

Primary Objectives

1. Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
2. Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

Conditions

  • Rotator Cuff Injuries
  • Rotator Cuff Tears
  • Subacromial Impingement
  • Subacromial Impingement Syndrome

Interventions

DRUG

Epinephrine

1 mL of 1:1000 mixed into irrigation bag.

DRUG

Tranexamic acid

1 g IV x 1 dose to be administered intraoperatively.

DRUG

Epinephrine and Tranexamic Acid

1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.

Sponsors & Collaborators

  • University of Manitoba

    collaborator OTHER
  • Panam Clinic

    lead OTHER

Principal Investigators

  • Jason Old, MD, FRCSC · Pan Am Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-10-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT04594408 on ClinicalTrials.gov