Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
NCT04594408 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2024-04-02
Summary
The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.
Primary Objectives
1. Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
2. Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization
Conditions
- Rotator Cuff Injuries
- Rotator Cuff Tears
- Subacromial Impingement
- Subacromial Impingement Syndrome
Interventions
- DRUG
-
1 mL of 1:1000 mixed into irrigation bag.
- DRUG
-
Tranexamic acid
1 g IV x 1 dose to be administered intraoperatively.
- DRUG
-
Epinephrine and Tranexamic Acid
1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.
Sponsors & Collaborators
-
University of Manitoba
collaborator OTHER -
Panam Clinic
lead OTHER
Principal Investigators
-
Jason Old, MD, FRCSC · Pan Am Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2021-10-01
- Completion
- 2024-01-01
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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