Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

NCT04865380 | Unknown Phase 3 FDA Drug

• 1 other identifier: BIO-1983
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Subacromial Impingement; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• Arthroscopic Visualization Score

  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

  Surgeon will complete the visualization score immediately after the surgery is completed.

Study Arms (2)

No Tranexamic Acid

NO INTERVENTION

The anesthesiologist will not administer Tranexamic Acid at any point.

Intravenous Tranexamic Acid

EXPERIMENTAL

1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.

Drug: Tranexamic Acid 100 MG/ML

Interventions

Tranexamic Acid 100 MG/ML DRUG

1g IV x 1 dose of Tranexamic Acid administered preoperatively.

Also known as: Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 02246365

Intravenous Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Dash & Reed Sports Medicine

White City, Saskatchewan, S4L 5B1, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jeremy Reed, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Reed, MD

CONTACT

3065664660; jreed@usask.ca

Michael W Thatcher, Bsc

CONTACT

3067379541; michael.thatcher@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons are blinded to group allocation and all treatment is administered by the anesthesia care provider. Patients will not be informed of their allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: January 13, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)