Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Postoperative Hemoglobin Loss. A Phase 2 Randomized Double-blind Monocentric Study. The PRADO study

This study, called PRADO, is testing a medicine called tranexamic acid to see how well it reduces blood loss during and after hip replacement surgery. People having hip replacements often lose blood, and sometimes need a blood transfusion. Researchers want to find the best dose of tranexamic acid to minimise this blood loss. They will compare different doses to a salt water solution (which doesn't contain the active medicine) in a carefully planned way. The main goal is to see how much a person's blood iron levels (haemoglobin) drop after surgery. They will also look at whether fewer patients need blood transfusions and check for any serious side effects like blood clots. This research is important for improving recovery for patients undergoing hip surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Enrolment target

170

Start

20 Apr 2023

Arthropathy of Hip

What is this study about?

This study, known as the PRADO study, is looking into how a medicine called tranexamic acid can help people having total hip replacement surgery. When you have a major operation like a hip replacement, it's normal to lose some blood. Sometimes, this blood loss can be significant, leading to low iron levels (anaemia) and even needing a blood transfusion.

Tranexamic acid is a medicine that helps the blood clot, and it's already used to reduce bleeding in various situations. This study specifically wants to find the best dose of tranexamic acid to give during and after hip surgery to keep blood loss to a minimum. They will compare different amounts of this medicine to a simple salt water solution, so they can clearly see if the medicine is working and at what dose it's most effective and safe.

By finding the right dose, doctors hope to reduce the amount of blood lost during surgery, lower the number of patients who need blood transfusions, and help patients recover more smoothly and quickly after their hip replacement. This research is a key step towards improving care for everyone undergoing this common operation.

Key takeaways

Tests different doses of a blood-clotting medicine (tranexamic acid) for hip surgery.
Aims to reduce blood loss and the need for transfusions during hip replacements.
Both men and women aged 18 and over, having hip surgery, can potentially join.
Participation involves receiving the study treatment and having blood tests before and after surgery.
Close monitoring for side effects like blood clots for up to 7 weeks.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. Both men and women can be considered for the study.

The study is specifically for people who are having a total hip replacement because of hip joint problems, like arthritis.

There might be other reasons why you can or cannot join, which the study team will discuss with you. These are to make sure the study is safe for you and that the results will be clear and helpful.

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 a total hip replacement operation?
Do you have hip joint problems, like arthritis?
Are you able to attend follow-up appointments for approximately 7 weeks after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to receive either one of the different doses of tranexamic acid or a salt water solution. This solution looks just like the study medicine, so neither you nor your doctors will know which one you are getting.

Before your surgery, blood samples will be taken to check your iron levels. During and after your surgery, you'll receive the study treatment. More blood samples will be taken on the fourth day after your operation to check your iron levels again. We'll also take blood samples to measure how the tranexamic acid behaves in your body and how it affects your blood clotting.

Throughout your hospital stay and up to about 45 days after your surgery, the study team will closely monitor you for any potential complications, such as blood clots or infections. You'll also have checks at the end of surgery, 24 hours later, and on day 8 to see the immediate effects of the medicine. The total duration of active follow-up for the study is about 7 weeks.

Potential risks and benefits

Taking part in this study could potentially help reduce your blood loss during and after hip replacement surgery, and possibly lower your chance of needing a blood transfusion. This could lead to a faster and smoother recovery. However, like all medicines, tranexamic acid can have side effects, and one rare but serious risk could be an increased chance of blood clots. The study team will carefully monitor you for any such issues. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is tranexamic acid?

It's a medicine that helps your blood clot, which can reduce bleeding during and after surgery.

Why is this study needed?

It helps doctors find the best and safest dose of tranexamic acid to minimise blood loss during hip replacement, improving patient recovery.

Will I know if I'm getting the active medicine or not?

No, it's a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study ends.

What is a 'hip replacement'?

It's an operation where a damaged hip joint is replaced with an artificial one, usually to relieve pain from conditions like arthritis.

What exactly will they measure in my blood?

They'll mainly check your iron levels (haemoglobin) to see how much blood you've lost, and also look at how the medicine is working and affecting your blood.