Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

NCT ID: NCT04865380

Last Updated: 2021-05-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tears Rotator Cuff Injuries Subacromial Impingement Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Surgeons are blinded to group allocation and all treatment is administered by the anesthesia care provider. Patients will not be informed of their allocation.

Study Groups

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No Tranexamic Acid

The anesthesiologist will not administer Tranexamic Acid at any point.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intravenous Tranexamic Acid

1g of Tranexamic Acid will be administered intravenously prior to the start of the operation.

Group Type EXPERIMENTAL

Tranexamic Acid 100 MG/ML

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 02246365

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Reed

Principle Investigator

Responsibility Role PRINCIPAL_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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jeremy Reed, MD

Role: CONTACT

3065664660

Michael W Thatcher, Bsc

Role: CONTACT

3067379541

Facility Contacts

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Jeremy Reed, MD

Role: primary

3065664660

Other Identifiers

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BIO-1983

Identifier Type: -

Identifier Source: org_study_id

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