Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
NCT ID: NCT04865380
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2021-01-13
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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No Tranexamic Acid
The anesthesiologist will not administer Tranexamic Acid at any point.
No interventions assigned to this group
Intravenous Tranexamic Acid
1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.
Tranexamic Acid 100 MG/ML
1g IV x 1 dose of Tranexamic Acid administered preoperatively.
Interventions
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Tranexamic Acid 100 MG/ML
1g IV x 1 dose of Tranexamic Acid administered preoperatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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University of Saskatchewan
OTHER
Responsible Party
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Jeremy Reed
Principle Investigator
Principal Investigators
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Jeremy Reed, MD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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Dash & Reed Sports Medicine
White City, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BIO-1983
Identifier Type: -
Identifier Source: org_study_id
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