Recruiting
Phase 3

Tranexamic Acid

Sponsor:

University of Saskatchewan

Code:

NCT04865380

Conditions

Rotator Cuff Tears

Rotator Cuff Injuries

Subacromial Impingement

Subacromial Impingement Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid 100 MG/ML

Study Details

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.

Conditions

Rotator Cuff Tears

Rotator Cuff Injuries

Subacromial Impingement

Subacromial Impingement Syndrome

Study ID

NCT04865380

Start date

Jan 13, 2021

Status verified date

Apr, 2021

Completion date

Apr, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No Tranexamic Acid

The anesthesiologist will not administer Tranexamic Acid at any point.

experimental: Intravenous Tranexamic Acid

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

Interventions

Tranexamic Acid 100 MG/ML

1g IV x 1 dose of Tranexamic Acid administered preoperatively.

Primary outcome measure

  • Arthroscopic Visualization Score [ Time Frame: Surgeon will complete the visualization score immediately after the surgery is completed. ]

Central Contacts and Locations

Central contacts

Jeremy Reed, MD

3065664660jreed@usask.ca

Michael W Thatcher, Bsc

3067379541michael.thatcher@usask.ca

Locations

Dash & Reed Sports Medicine

Recruiting

White City, Saskatchewan, Canada, S4L 5B1

Contacts

Jeremy Reed, MD

3065664660jreed@usask.ca

Principal Investigator:

Jeremy Reed, MD

More Information

Sponsor

University of Saskatchewan

Last update posted

May 3, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2021-05-03.