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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
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 26, 2021
Last Updated
April 28, 2021
Sponsor
University of Saskatchewan
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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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