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Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04594408
Recruitment Status : Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : March 28, 2023
University of Manitoba
Information provided by (Responsible Party):
Panam Clinic

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

  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

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2020
Actual Primary Completion Date : October 1, 2021
Estimated Study Completion Date : September 1, 2023

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 Name: Epi

Experimental: Intravenous TXA
Tranexamic acid intervention used.
Drug: Tranexamic acid
1 g IV x 1 dose to be administered intraoperatively.
Other Name: 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 Name: TXA, Epi

Primary Outcome Measures :
  1. Visualization Quality Scale [ Time Frame: 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 :
  1. Patient Log Book for Pain and Medications [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594408

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Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
Panam Clinic
University of Manitoba
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Principal Investigator: Jason Old, MD, FRCSC Pan Am Clinic

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Responsible Party: Panam Clinic
ClinicalTrials.gov Identifier: NCT04594408    
Other Study ID Numbers: PA2018-001
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Tranexamic Acid
Epinephryl borate
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents