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Drug may sharpen Surgeon's view during shoulder operations

NCT ID NCT05397652

Symptom relief Sponsor: Nikola Matejcic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving tranexamic acid (TXA) before shoulder arthroscopy improves the surgeon's view and reduces bleeding. 121 adults with rotator cuff tears received either TXA or a placebo. The main goal was to see if TXA makes the surgery clearer and safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid
What this could lead to
If it works, this could make shoulder surgery safer and clearer for surgeons, potentially reducing complications and speeding up recovery.
What could go wrong
This is a small, single-center trial. Tranexamic acid carries a small risk of blood clots, and the benefits may not apply to all patients or surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

121 people

The number who actually took part.

Started

May 2021

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Hemorrhage Rotator Cuff Injuries rotator cuff syndrome Shoulder Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhage, surgical Rotator cuff tears Shoulder injuries

Contacts and locations

Locations

  • University orthopaedic and trauma hospital

    Lovran, Primorje-Gorski Kotar County, 51415, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.