Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement, Subacromial Impingement Syndrome
Conditions
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.
Interventions
1g IV x 1 dose of Tranexamic Acid administered preoperatively.
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Surgeons are blinded to group allocation and all treatment is administered by the anesthesia care provider. Patients will not be informed of their allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactJeremy Reed, MD
Backup ContactMichael W Thatcher, Bsc
Outcome results
None listed