Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

Phase 3

• Conditions: Rotator Cuff Tears; Rotator Cuff Injuries; Subacromial Impingement Syndrome; Subacromial Impingement
• Interventions: Drug: Tranexamic Acid 100 MG/ML

• Registration Number: NCT04865380
• Lead Sponsor: University of Saskatchewan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Status Verified: 2021-04
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-05-03
• Primary Completion: 2021-12
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Tranexamic Acid	Tranexamic Acid 100 MG/ML	1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.

Primary Outcome Measures

Name	Time	Method
Arthroscopic Visualization Score	Surgeon will complete the visualization score immediately after the surgery is completed.	A visualization score from 1 to 6 assessed by the surgeon.; 1. - Perfect visualization; 2. - Mild difficulty that could easily be worked around; 3. - Moderate difficulty that required modifications to the surgical plan; 4. - Significant difficulty that added more than 10 minutes to the case; 5. - Major difficulty that added more than 20 minutes to the case; 6. - Difficulty that forced the stoppage of the case

Trial Locations

Locations (1)

Dash & Reed Sports Medicine; 🇨🇦 White City, Saskatchewan, Canada