NCT04594408

Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Panam Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

In the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. The interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. Obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively. A variety of methods have been employed to improve visualization. This includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. The use of epinephrine in irrigation fluid has been studied in literature. The results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. However, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. Therefore, it is important to examine other alternatives, such as TXA, that can decrease bleeding and improve visualization without potential detrimental effects. This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-10-01
• Completion: 2024-01-01
• First posted: 2020-10-20
• Last updated: 2024-04-02

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study