Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Subacromial Impingement Syndrome; Rotator Cuff Tears; Subacromial Impingement
• Intervention / Treatment: Drug: Tranexamic Acid 100 MG/ML

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jeremy Reed, MD; Phone Number: 3065664660; Email: jreed@usask.ca
• Study Contact Backup: Name: Michael W Thatcher, Bsc; Phone Number: 3067379541; Email: michael.thatcher@usask.ca

Study Locations

• Canada
  • Saskatchewan
    • White City, Saskatchewan, Canada, S4L 5B1
      • Recruiting
      • Dash & Reed Sports Medicine
      • Contact: Jeremy Reed, MD; Phone Number: 3065664660; Email: jreed@usask.ca
      • Principal Investigator: Jeremy Reed, MD
      • Sub-Investigator: Michael Thatcher, Bsc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jeremy Reed, MD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: BIO-1983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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