Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.

Official Title
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Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial

Conditions
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Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement, Subacromial Impingement Syndrome

Intervention / Treatment
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* Drug: Tranexamic Acid 100 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-100 Male and Female Patient able to read and understand consent form Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI Booked to operating room for elective rotator cuff repair Beach chair positioning Exclusion Criteria: Patient refusal to participate Massive rotator cuff tear Acute traumatic rotator cuff tear Known coagulopathy Patients with a history or risk of thromboembolism Known hypersensitivity to tranexamic acid Patient unable to be off anti-coagulant medication for long enough to counter effects Patient has a clinic systolic blood pressure > 150mmHg Lateral positioning Requirement or insistence by patient or anesthesiologist on regional block Patients who have smoked nicotine products within the last year The presence of other inflammatory conditions (calcific tendonitis, rheumatoid arthritis, etc.) The presence of active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis Patient has a seizure disorder Patients on medications identified as having drug-drug interactions (hormonal contraceptive, hydrochlorothiazide, desmopressin, sulbactam-ampicilllin, carbazochrome, ranitidine, or nitroglycerine Patient is pregnant Patients with history of subarachnoid hemorrhage Patients with renal insufficiency Patients with acquired disturbances of color vision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Tranexamic Acid<br>The anesthesiologist will not administer Tranexamic Acid at any point. | |
| Experimental: Intravenous Tranexamic Acid<br>1g of Tranexamic Acid will be administered intravenously prior to the start of the operation. | Drug: Tranexamic Acid 100 MG/ML<br>* 1g IV x 1 dose of Tranexamic Acid administered preoperatively.<br>* Other names: Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 02246365;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopic Visualization Score | A visualization score from 1 to 6 assessed by the surgeon. - Perfect visualization - Mild difficulty that could easily be worked around - Moderate difficulty that required modifications to the surgical plan - Significant difficulty that added more than 10 minutes to the case - Major difficulty that added more than 20 minutes to the case - Difficulty that forced the stoppage of the case | Surgeon will complete the visualization score immediately after the surgery is completed. |