Back to results

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

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

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

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

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

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

jreed@usask.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Michael W Thatcher, Bsc

Phone

3067379541

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

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

Learn more about this trial

Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

We'll reach out to this number within 24 hrs