Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair

University of Saskatchewan

Status and phase: Unknown; Phase 3

Conditions: Subacromial Impingement; Subacromial Impingement Syndrome; Rotator Cuff Injuries; Rotator Cuff Tears

Treatments: Drug: Tranexamic Acid 100 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04865380

BIO-1983

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

No Tranexamic Acid

No Intervention group

Description:

The anesthesiologist will not administer Tranexamic Acid at any point.

Intravenous Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid 100 MG/ML