CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
Epinephrine +2 moredrug
Likely dose
Epinephrine 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04594408
NCT04594408Phase 4Completed
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The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial

Panam Clinic·interventional·Posted Oct 20, 2020·Updated Apr 2, 2024

In Brief

A Phase 4 clinical trial evaluating Epinephrine, Tranexamic acid, and 1 other intervention for Rotator Cuff Injuries and 3 related conditions. Completed, enrolled 128 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotator Cuff Injuries, Rotator Cuff Tears, Subacromial Impingement, Subacromial Impingement Syndrome
CountriesCanada
CollaboratorsUniversity of Manitoba

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedOct 20, 2020
Enrollment StartSep 1, 2020
Primary CompletionOct 1, 2021
Study CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

Epinephrinedrug

1 mL of 1:1000 mixed into irrigation bag.

Tranexamic aciddrug

1 g IV x 1 dose to be administered intraoperatively.

Epinephrine and Tranexamic Aciddrug

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