Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
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| ClinicalTrials.gov Identifier: NCT04594408 |
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Recruitment Status :
Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : March 28, 2023
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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 |
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 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 |
|---|---|
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No Intervention: No epinephrine or TXA
No intervention given.
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Active Comparator: Epinephrine in irrigation fluid
Epinephrine intervention used.
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Drug: Epinephrine
1 mL of 1:1000 mixed into irrigation bag.
Other Name: Epi |
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Experimental: Intravenous TXA
Tranexamic acid intervention used.
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Drug: Tranexamic acid
1 g IV x 1 dose to be administered intraoperatively.
Other Name: TXA |
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Experimental: Epinephrine and TXA
Epinephrine and tranexamic acid intervention used.
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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 |
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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
| Canada, Manitoba | |
| Pan Am Clinic | |
| Winnipeg, Manitoba, Canada, R3M 3E4 | |
| Principal Investigator: | Jason Old, MD, FRCSC | Pan Am Clinic |
| 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 |
| 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 |
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Shoulder Impingement Syndrome Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries Joint Diseases Musculoskeletal Diseases Epinephrine Racepinephrine Tranexamic Acid Epinephryl borate Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
Hemostatics Coagulants 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 Mydriatics Sympathomimetics |