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Study on Tranexamic Acid to Reduce Blood Loss in Hip Replacement Surgery for Patients with Hip Arthropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called tranexamic acid in patients undergoing total hip replacement surgery. The main goal is to see how different doses of this medication can help reduce the loss of hemoglobin, which is a protein in red blood cells that carries oxygen, during and after the surgery. The study is designed to be a randomized and double-blind trial, meaning neither the patients nor the researchers know who is receiving the actual medication or a placebo, to ensure unbiased results.

Participants in the study will receive tranexamic acid through an infusion, which is a method of delivering medication directly into the bloodstream. The study will also involve the use of sodium chloride solution, commonly known as saline, which is often used in medical settings to provide hydration and as a vehicle for other medications. Additionally, some participants may receive apixaban, a medication that helps prevent blood clots, taken orally in the form of a tablet.

The study will monitor the participants' hemoglobin levels before the surgery and on the eighth day after the surgery to measure any changes. It will also look at the concentration of tranexamic acid in the blood and other factors like the need for blood transfusions and the occurrence of any blood clots or other serious events. The study aims to provide valuable information on how to best use tranexamic acid to improve outcomes for patients undergoing hip replacement surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide consent. This can be given by you, a family member, or a support person.

    You will be informed about the study's purpose, which is to evaluate the effect of different doses of tranexamic acid on reducing blood loss during and after hip replacement surgery.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, a blood sample will be taken to measure your hemoglobin levels. Hemoglobin is a protein in your blood that carries oxygen.

    You will receive an infusion of tranexamic acid and sodium chloride as part of the study. The tranexamic acid is given to help reduce bleeding during surgery.

  3. Step 3

    Surgery day

    On the day of your hip replacement surgery, the medical team will administer the study medications as planned.

    The surgery will proceed as scheduled, and the study team will monitor your condition closely.

  4. Step 4

    Post-surgery monitoring

    After the surgery, your hemoglobin levels will be checked again on the eighth day to assess any changes.

    You may also have blood samples taken to measure the concentration of tranexamic acid and other markers in your blood.

  5. Step 5

    Medication administration

    During the recovery period, you will be given apixaban orally. Apixaban is a medication that helps prevent blood clots.

    The dosage and frequency of apixaban will be determined by the study protocol and your medical team.

  6. Step 6

    Follow-up and evaluation

    Throughout the study, the team will monitor for any signs of anemia, which is a condition where you have a lower than normal number of red blood cells.

    The study will also track any potential complications, such as blood clots or other serious events.

Who can join the trial?

4 criteria

  • The patient must need a primary hip arthroplasty, which means they are having their first hip replacement surgery, and it should be scheduled within the next 3 months.
  • The patient, or a family member or support person, must give their consent to participate in the study.
  • Both men and women can participate in the study.
  • The study is open to adults, which means participants should be in the age range of 18 to 64 years or 65 years and older.

Who cannot join the trial?

3 criteria

  • Patients with any condition other than Arthropathy of Hip cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Tranexamic Acid is a medication used in this clinical trial to help reduce bleeding during and after surgery. It works by preventing the breakdown of blood clots, which helps to minimize blood loss. In this study, it is being tested to see how effective it is at different doses in reducing the amount of blood lost during total hip replacement surgery. This can be important for patients because losing less blood during surgery can lead to a quicker recovery and fewer complications. The study aims to find the best dose that provides the most benefit in terms of reducing blood loss.

What is already known about the treatment

Tranexamic Acid – Tranexamic Acid is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to understand its effectiveness in reducing blood loss during and after hip replacement surgery. The main therapeutic use of Tranexamic Acid is to prevent excessive bleeding, particularly in surgical settings. At the molecular level, it works by blocking the breakdown of blood clots, helping to maintain clot stability and reduce bleeding. It is classified pharmacologically as an antifibrinolytic agent, which means it helps prevent the breakdown of fibrin, a protein that is crucial for blood clot formation.

Investigated diseases

Arthropathy of Hip – Arthropathy of the hip refers to a condition affecting the hip joint, characterized by inflammation and degeneration. It often involves the breakdown of cartilage, leading to pain and stiffness in the hip area. As the disease progresses, individuals may experience reduced range of motion and difficulty in performing daily activities. Over time, the joint may become deformed, and bone spurs can develop, further limiting movement. The condition can result from various causes, including osteoarthritis, rheumatoid arthritis, or traumatic injury. It is a common condition, particularly in older adults, and can significantly impact quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502532-38-01Protocol code18CH052Estimated enrolment170 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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