Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

Panam Clinic

Status and phase: Completed; Phase 4

Conditions: Subacromial Impingement; Subacromial Impingement Syndrome; Rotator Cuff Tears; Rotator Cuff Injuries

Treatments: Drug: Tranexamic acid; Drug: Epinephrine and Tranexamic Acid; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04594408

PA2018-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

128 participants in 4 patient groups

No epinephrine or TXA

No Intervention group

Description:

No intervention given.

Epinephrine in irrigation fluid

Active Comparator group

Description:

Epinephrine intervention used.

Treatment:

Drug: Epinephrine

Intravenous TXA

Experimental group

Description:

Tranexamic acid intervention used.

Treatment:

Drug: Tranexamic acid

Epinephrine and TXA

Experimental group

Description:

Epinephrine and tranexamic acid intervention used.

Treatment:

Drug: Epinephrine and Tranexamic Acid