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RecruitingTherapeutic use (Phase IV)Interventional

“Randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in patients with hip fracture”.

A broken hip is a major injury that usually requires surgery. During and after the operation, patients can lose significant amounts of blood, which sometimes means they need a blood transfusion. This clinical trial tests a medicine called tranexamic acid, which helps blood to clot and reduces bleeding. Researchers want to find out if giving this medicine to patients with a hip fracture reduces overall blood loss and decreases the need for donor blood transfusions. Participants will have routine blood tests and vital sign checks during their hospital stay to monitor their blood levels. The study team will also track recovery, mobility, and general health for up to 12 months after surgery. Taking part helps doctors learn the safest, most effective ways to treat people with hip fractures in the NHS.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Asociacion Instituto Biogipuzkoa
Enrolment target
644
Start
11 Nov 2024

What is this study about?

A hip fracture is a serious break near the top of the thigh bone that usually needs prompt surgery to repair or replace the joint. Hip surgery can lead to heavy bleeding, which can make people feel very tired, weak, and dizzy. In some cases, blood levels drop low enough that a patient needs a blood transfusion to help them recover safely.

Tranexamic acid is a well-known medicine that stops blood clots from breaking down too quickly, helping the body manage bleeding. While it is already used in many planned operations, such as scheduled knee replacements, researchers want clear evidence on how well it works for sudden emergencies like hip fractures. This trial aims to discover if giving tranexamic acid reduces blood loss from the moment of injury through to hospital discharge.

Doctors will carefully measure blood counts and keep a close eye on patient recovery. By finding out whether tranexamic acid reduces the need for blood transfusions without causing unwanted side effects, this study could help improve standard care and recovery times for thousands of older adults admitted to hospital each year.

Key takeaways

  • Tests whether tranexamic acid reduces bleeding in hip fracture surgery.
  • Aims to reduce the need for blood transfusions.
  • Open to adults aged 18 and over with a broken hip.
  • Involves standard blood checks during hospital stay and follow-ups for up to one year.
  • Your routine surgical care and emergency treatments will not be delayed.

Who may be eligible?

This trial is designed for adults aged 18 and older who have been admitted to hospital with a hip fracture that requires surgery. Both men and women can take part.

Because this study specifically focuses on hip fractures, it is not suitable for people with other types of broken bones. The hospital team will check your overall health and review any regular medicines you take, particularly blood thinners, to make sure it is safe for you to take part.

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 admitted to hospital with a hip fracture.
  3. I am scheduled to have surgery to treat my broken hip.
  4. I am willing to have regular blood tests and follow-up checks for 12 months.
Answer every question to see your result.

What does participation involve?

If you take part, you will be allocated by chance to receive either tranexamic acid or a standard comparison treatment (such as a dummy medicine or standard care) around the time of your hip surgery. Neither you nor your doctors will choose which group you are in, ensuring the test is fair. While you are in hospital, staff will take regular blood samples to check your red blood cell levels (haemoglobin) and monitor your blood pressure and pulse. If you need a blood transfusion at any point, you will receive one immediately. After you leave the hospital, the study team will follow up on your progress at 3, 6, 9, and 12 months to see how well you are walking, check your general health, and make sure you have had no complications.

Potential risks and benefits

You may benefit from receiving a medicine that reduces blood loss and lowers your chances of needing a blood transfusion, though this cannot be guaranteed. Your participation will also help improve treatment for future hip fracture patients. Tranexamic acid is widely used, but all medicines can have side effects, and the doctors will watch closely for any complications such as blood clots or infections. Taking part is completely voluntary; you can choose to leave the study at any time without your normal NHS care or treatment being affected.

Locations (1)

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

Common questions

What is tranexamic acid?

It is a medicine that helps blood clots stay intact, which slows down or stops bleeding during and after surgery.

Will I definitely receive the study medicine?

Not necessarily. This is a randomised study, meaning a computer randomly decides whether you receive tranexamic acid or a comparison treatment.

Will joining this trial delay my hip operation?

No. Your hip surgery will happen as planned according to the hospital's normal urgent schedule.

What happens if I lose a lot of blood during surgery?

Your safety always comes first. If your blood levels drop too low, your surgical team will give you a blood transfusion straight away, regardless of which study group you are in.

Do I have to attend extra hospital visits after I go home?

Follow-ups at 3, 6, 9, and 12 months are often done over the phone or during routine clinic appointments so you do not have to make unnecessary trips.

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 "“Randomized, double-blind clinical trial to assess the effic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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