Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865380
• Other study ID #: BIO-1983
• Status: Recruiting
• Phase: Phase 3
• Start date: January 13, 2021
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• Source: University of Saskatchewan
• Contact: Jeremy Reed, MD
• Phone: 3065664660
• Email: jreed[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Impingement Syndrome
• Subacromial Impingement
• Subacromial Impingement Syndrome

Intervention

Drug:
• Tranexamic Acid 100 MG/ML
1g IV x 1 dose of Tranexamic Acid administered preoperatively.

Locations

Country	Name	City	State
Canada	Dash & Reed Sports Medicine	White City	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.