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RecruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty

Hip replacement surgery is a common and effective operation for people living with painful hip osteoarthritis. However, like any major surgery, it can lead to blood loss. Tranexamic acid is a well-known medicine that helps the blood clot and prevents heavy bleeding. In this study, surgeons are testing what happens when tranexamic acid is injected directly into the hip joint during the operation. Researchers want to measure the exact amount of blood lost 24 hours and 48 hours after surgery. The aim is to find out if this simple step helps patients lose less blood, recover more comfortably, and avoid the need for blood transfusions. The trial is open to adults aged 18 and over who are already scheduled for hip replacement surgery.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Region Hovedstaden
Enrolment target
100
Start
15 Nov 2024

What is this study about?

Osteoarthritis is a condition that wears away the smooth cartilage inside our joints. Over time, the hip can become stiff, swollen, and very painful. When treatments like painkillers and gentle exercise are no longer enough, doctors often recommend a total hip replacement. During this operation, the damaged bone and cartilage are removed and replaced with an artificial hip joint.

Bleeding is a normal part of any major operation, but losing too much blood can cause tiredness, slow down recovery, and sometimes mean a patient needs a blood transfusion. Tranexamic acid is a medicine that helps the body protect its natural blood clots to control bleeding. In this trial, doctors want to see the effect of placing this medicine straight into the hip joint space while the operation is taking place.

By comparing results, researchers hope to confirm whether this method significantly cuts down blood loss in the first two days of recovery. If it is successful, this technique could help make hip replacements safer and help patients get back on their feet more quickly.

Key takeaways

  • Tests whether injecting tranexamic acid into the hip joint reduces bleeding after surgery.
  • Aimed at adults aged 18 and older having a total hip replacement for osteoarthritis.
  • Measures total blood loss at 24 hours and 48 hours after the operation.
  • Takes place entirely during your normal hospital stay with no extra visits needed.
  • Taking part is completely voluntary and will not change your standard NHS treatment.

Who may be eligible?

This trial is open to adults aged 18 and over who have hip osteoarthritis and are booked to have a planned total hip replacement surgery. Both men and women can take part.

Because this involves surgery and a blood-clotting medicine, your surgical team will carefully review your general health. They will check your medical history to make sure that tranexamic acid is safe for you and that you do not have any conditions that would make taking part risky.

If you have had severe allergic reactions to this medicine in the past or have certain blood clotting disorders, you may not be able to join. Your hospital team will talk through all these details with you before you decide.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with osteoarthritis in my hip.
  3. I am scheduled to have a total hip replacement surgery.
  4. I am happy to have my recovery and blood loss monitored for two days after surgery.
Answer every question to see your result.

What does participation involve?

Taking part in this study takes place while you are already in the hospital for your planned hip replacement. During your operation, the surgical team will administer the tranexamic acid injection directly into your hip joint. After your surgery, the nursing and medical teams will care for you as normal. They will carefully track and measure your blood loss 24 hours after surgery and again on the morning of your second day in hospital. You will not need extra clinic visits beyond your routine post-surgery checks, and taking part will not extend your normal hospital stay.

Potential risks and benefits

A potential benefit of joining this study is that you may lose less blood during and after your surgery, which can reduce bruising, swelling, and the need for a blood transfusion. However, benefits cannot be guaranteed. Tranexamic acid is widely used, but possible side effects can include mild nausea, dizziness, or rare allergic reactions. Taking part is completely voluntary. You are free to say no or withdraw at any point, and your decision will never affect the standard of care you receive from the NHS.

Locations (1)

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

Common questions

What is tranexamic acid?

It is an established medicine that helps stop blood clots from breaking down too quickly, which helps reduce bleeding during and after surgery.

Will taking part make my operation take longer?

No. Giving the injection into the hip joint takes only a moment and will not noticeably change the length of your surgery.

Will I have to stay in hospital longer?

No. The measurements are taken during the first 48 hours after surgery, which is typically within the normal hospital stay for a hip replacement.

Does it cost anything to join the study?

No. The treatment and all study assessments are provided free of charge as part of your hospital care.

Can I change my mind later?

Yes. You can withdraw from the study at any time without giving a reason, and it will not affect your ongoing medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of intra articular Tranexamic acid for reduction …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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