Status:
UNKNOWN
Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
Lead Sponsor:
University of Saskatchewan
Conditions:
Rotator Cuff Tears
Rotator Cuff Injuries
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04865380
Start Date
January 13 2021
End Date
April 1 2022
Last Update
May 3 2021
Active Locations (1)
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1
Dash & Reed Sports Medicine
White City, Saskatchewan, Canada, S4L 5B1