Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

Sponsor

Panam Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04594408

Collaborator

University of Manitoba (Other)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

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

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Injuries Rotator Cuff Tears Subacromial Impingement Subacromial Impingement Syndrome	Drug: Epinephrine Drug: Tranexamic acid Drug: Epinephrine and Tranexamic Acid	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Surgeons are blinded to group allocation as all IV bags will have labels appearing identical when turned away from the surgeon. Anesthetists are told not to reveal allocation to the surgeon as well. And patients will not be informed of their allocation.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No epinephrine or TXA No intervention given.
Active Comparator: Epinephrine in irrigation fluid Epinephrine intervention used.	Drug: Epinephrine 1 mL of 1:1000 mixed into irrigation bag. Other Names: Epi
Experimental: Intravenous TXA Tranexamic acid intervention used.	Drug: Tranexamic acid 1 g IV x 1 dose to be administered intraoperatively. Other Names: TXA
Experimental: Epinephrine and TXA Epinephrine and tranexamic acid intervention used.	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. Other Names: TXA, Epi

Outcome Measures

Primary Outcome Measures

Visualization Quality Scale [Intra-operative]
Surgeons are asked every 15 minutes to report on the quality of visualization based on a 4-point scale. Minimum value is 0, maximum value is 3 with the higher value reflecting improved visualization

Secondary Outcome Measures

Patient Log Book for Pain and Medications [Day of surgery - post-operative day 14]
Patients are sent home from surgery with a log book to track the level of pain they are experiencing as well as the medications that they take.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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