AuthorisedTherapeutic confirmatory (Phase III)Interventional

Tranexamic Acid in Hind and Midfoot Arthrodesis Surgery: A Multicentre, Randomized, Placebo-Controlled Trial (TRASH Trial)

This research study, called the TRASH Trial, investigates whether a medicine called tranexamic acid can help prevent problems after foot and ankle surgery. These surgeries are often done to treat conditions like arthritis or deformities in the foot. We are specifically looking at how well it prevents infections in the wound after surgery, considering both minor and more serious infections, over a year. The study also explores if it reduces blood loss during surgery, helps wounds heal, and improves fusion rates if bones are being joined together. Participants will receive either tranexamic acid or a dummy treatment (placebo) through a drip. We hope this study will help us find better ways to improve recovery for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

HUS-yhtymae

Enrolment target

450

Start

29 May 2026

Deformity, Osteoarthritis

What is this study about?

This study, called the TRASH Trial, is looking into how we can make surgery on the midfoot and hindfoot (that's the back and middle part of your foot) even safer and more successful. People often have these operations because of conditions like arthritis, where their joints get worn out, or if their foot has a deformity that needs correcting. During these operations, some bleeding is normal, and sometimes patients can get infections afterwards, even with the best care.

The main aim of our study is to see if a medicine called tranexamic acid can help prevent wound infections after these foot surgeries. Tranexamic acid is a medicine that helps the blood clot, so it might reduce bleeding during surgery. We want to find out if this leads to fewer infections and other complications in the year following the operation, compared to people who receive a dummy treatment (a placebo) that looks just like the real medicine but has no active ingredient. This is a common and important way to test new treatments.

We'll be carefully checking a few things. Our main focus is on infections: whether they are minor (on the surface) or more serious (deeper down). We'll also be looking at how much blood is lost during surgery, how well wounds heal, and if any bones that were joined together (which is called fusion) have successfully grown together after 12 months. We'll also ask about your pain and how your foot is working, to understand the full impact of the treatment. By doing this research, we hope to find ways to improve recovery and outcomes for patients having foot and ankle surgery.

Key takeaways

The study tests tranexamic acid to prevent infections after foot/ankle surgery.
It's for people having midfoot or hindfoot surgery due to arthritis or deformity.
Participants will receive either the study medicine or a dummy treatment during surgery.
The main goal is to see if it reduces wound infections over one year.
You'll have follow-up appointments, blood tests, and a scan over 12 months.
Joining is voluntary, and you can leave at any time.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You might be considered for the study if you are planning to have surgery on your midfoot or hindfoot because of conditions like arthritis or a foot deformity.

There might be some specific health conditions or medications that would mean you couldn't take part, as these could affect the safety of the medicine being studied or the results of the trial. The research team will carefully check your medical history to make sure the study is right for you.

If you're interested, the doctors and nurses will fully explain all the requirements and answer any questions you have to help you decide if you're a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery on your midfoot or hindfoot?
Is your surgery for conditions like arthritis or a foot deformity?
Are you able to attend follow-up appointments for 12 months after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medicine (tranexamic acid) or a dummy treatment (placebo) through a drip during your surgery. This will be decided by chance, like flipping a coin, so neither you nor your doctor will know which one you are getting.

After your surgery, you will have several check-ups. A specialist nurse or surgeon will look at your wound after about 2 weeks, then again at 3 months, and finally at 12 months. You'll also have blood tests on the day of your surgery to check for blood loss. At the 12-month visit, you will have a special scan (called a CT scan) to see how well any bones that were joined together have healed. Throughout the year, you'll also be asked to complete some questionnaires about your pain, how your foot is feeling, and how it affects your daily life. The total duration of your active participation, including all follow-up, will be for 12 months after your surgery.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. You might not directly benefit from taking part, but the information we gather could help improve care for future patients. Potential risks could include side effects from the study medicine, though tranexamic acid is a commonly used medication, or complications from the extra tests like blood samples or scans. All study procedures will be thoroughly explained, and your safety will be closely monitored by the research team throughout. Remember, you can choose to join or leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is tranexamic acid?

Tranexamic acid is a medicine that helps your blood to clot, which can reduce bleeding during and after surgery.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps us compare the real medicine's effects accurately.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your doctors will know whether you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure fair and unbiased results.

What kind of foot surgeries are included?

This study includes operations on the midfoot and hindfoot (the middle and back parts of your foot), often for conditions like arthritis or correcting a foot deformity.

How long will I be in the study?

Your participation in the study, including all follow-up appointments, will last for 12 months after your surgery.