CompletedPhase 4

Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position

Croatia121 participantsStarted 2021-05-24

Plain-language summary

Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- rotator cuff tear Exclusion Criteria: * allergy to tranexamic acid, paracetamol (acetaminophen), ketoprofen, tramadol or metamizole sodium * deep vein thrombosis * congenital thrombophilia * coagulopathy * thromboembolic events within the previous 12 months * stroke or acute coronary syndrome within the previous 3 months * renal failure * liver cirrhosis * glaucoma or retinal vascular disorder * chronic treatment with anticoagulant or antiplatelet therapy * uncontrolled hypertension (systolic blood pressure \> 180 mmHg)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative)

Timeframe: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes

Trial details

NCT IDNCT05397652

SponsorNikola Matejcic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-21

Results submitted2025-12-22

View on ClinicalTrials.gov More Rotator Cuff Tears trials