Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
Primary Purpose
Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid 100 MG/ML
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
Eligibility Criteria
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
Sites / Locations
- Dash & Reed Sports MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Tranexamic Acid
Intravenous Tranexamic Acid
Arm Description
The anesthesiologist will not administer Tranexamic Acid at any point.
1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04865380
First Posted
April 26, 2021
Last Updated
April 28, 2021
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT04865380
Brief Title
Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
Official Title
Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement, Subacromial Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Tranexamic Acid
Arm Type
No Intervention
Arm Description
The anesthesiologist will not administer Tranexamic Acid at any point.
Arm Title
Intravenous Tranexamic Acid
Arm Type
Experimental
Arm Description
1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 100 MG/ML
Other Intervention Name(s)
Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 02246365
Intervention Description
1g IV x 1 dose of Tranexamic Acid administered preoperatively.
Primary Outcome Measure Information:
Title
Arthroscopic Visualization Score
Description
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
Time Frame
Surgeon will complete the visualization score immediately after the surgery is completed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Reed, MD
Phone
3065664660
Email
jreed@usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael W Thatcher, Bsc
Phone
3067379541
Email
michael.thatcher@usask.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Reed, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dash & Reed Sports Medicine
City
White City
State/Province
Saskatchewan
ZIP/Postal Code
S4L 5B1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Reed, MD
Phone
3065664660
Email
jreed@usask.ca
First Name & Middle Initial & Last Name & Degree
Jeremy Reed, MD
First Name & Middle Initial & Last Name & Degree
Michael Thatcher, Bsc
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
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