Trial | NCT04594408  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    128
The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.

Primary Objectives

Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization
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.
Study Started
Sep 01
2020
Primary Completion
Oct 01
2021
Study Completion
Sep 01
2023
Anticipated
Last Update
Mar 28
2023

Drug Epinephrine

1 mL of 1:1000 mixed into irrigation bag.

  • Other names: Epi

Drug Tranexamic acid

1 g IV x 1 dose to be administered intraoperatively.

  • Other names: TXA

Drug Epinephrine and Tranexamic Acid [epinephrine (levophed), tranexamic acid (cyklokapron)]

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

  • Other names: TXA, Epi

No epinephrine or TXA No Intervention

No intervention given.

Epinephrine in irrigation fluid Active Comparator

Epinephrine intervention used.

Intravenous TXA Experimental

Tranexamic acid intervention used.

Epinephrine and TXA Experimental

Epinephrine and tranexamic acid intervention used.

Criteria 

Inclusion Criteria:

Able to read and understand patient consent form and give informed consent
Rotator cuff pathology or impingement that have clinical indications for shoulder arthroscopy surgery (either rotator cuff repair or subacromial decompression

Exclusion Criteria:

Have an active thromboembolic event
Allergies or hypersensitivies to TXA or any of the ingredients
Have a seizure disorder
On hormonal contraceptives
Pregnant
History of venous thromboembolism in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as a cerebrovascular event (stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolism or with a history of hypercoagulable disorders (i.e. Factor V Lieden, antiphospholipid antibody)
Acquired disturbances of colour vision
Hematuria with renal cause
No Results Posted