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Efficacy of Tranexamic Acid in Reducing Perioperative Blood Loss in Patients with Hip Fracture: A Randomized, Double-Blind Clinical Trial

Verified siteRegistered drugNo placebo
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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 tranexamic acid in patients who have experienced a hip fracture. Tranexamic acid is a medication that helps reduce bleeding. The purpose of the study is to see if using tranexamic acid can lower the amount of blood loss in these patients, which might reduce the need for blood transfusions.

During the study, patients will receive tranexamic acid through an intravenous (IV) line when they are admitted to the hospital and during their surgery. The study will monitor the patients' blood levels and overall health to see how effective the treatment is in reducing blood loss. The study will also track any side effects or complications that may occur during the hospital stay and up to a year after surgery.

The study aims to provide valuable information on whether tranexamic acid can help patients with hip fractures by reducing the need for blood transfusions and improving recovery outcomes. This research could lead to better treatment options for individuals suffering from hip fractures in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Hospital admission

    Upon admission to the hospital for a hip fracture, a baseline measurement of hemoglobin (a protein in red blood cells that carries oxygen) and hematocrit (the proportion of red blood cells in the blood) is performed.

    Vital signs and physical symptoms are monitored to evaluate the need for a blood transfusion, which is the process of receiving blood or blood components.

  2. Step 2

    Medication administration

    The medication tranexamic acid is administered through an intravenous route, which means it is delivered directly into a vein.

    The dosage is 40 mg/kg, where mg/kg refers to milligrams of the medicine for every kilogram of body weight.

  3. Step 3

    Monitoring and blood tests

    Blood levels of hemoglobin and hematocrit are measured on day 0, day 1, day 2, and day 3.

    Additional hemoglobin measurements are taken at specific intervals labeled as preq, postq1, postq2, and postq3.

    The total amount of blood loss is tracked from the time of the fracture until hospital admission, and from admission until surgery.

  4. Step 4

    Surgical and discharge phase

    The date of the surgical intervention and the type of surgery performed are recorded.

    The length of the hospital stay is monitored until the date of hospital discharge.

  5. Step 5

    Follow-up period

    Health status is monitored for potential adverse events, which are unexpected or harmful medical occurrences, at 3, 6, 9, and 12 months after the surgery.

    Observations include monitoring for blood clots in the legs or lungs, stroke, heart attack, infections, changes in mental clarity, or the need for reoperation.

Who can join the trial?

4 criteria

  • You must be older than 65 years of age.
  • The study is open to both males and females.
  • You or a family member or legal representative must provide informed consent, which is a signed document showing that you agree to participate after understanding the details of the study.
  • You must have a hip fracture, which is a type of broken bone in the hip area.

Who cannot join the trial?

6 criteria

  • You are currently taking another experimental drug, which is a medicine that is still being tested to see if it is safe and works well.
  • You do not give your consent, which means you do not agree to take part in the study.
  • You have a known allergy, which is an immune system reaction, to TXA (tranexamic acid).
  • You have a history of seizures, which are sudden, uncontrolled electrical disturbances in the brain that can cause changes in behavior or movement.
  • You have severe kidney failure, which means your kidneys are not working well enough to filter waste from your blood.
  • You have severe liver failure, which means your liver is unable to perform its necessary functions for your body.
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Investigated drugs

Tranexamic acid is a medication given through a vein to help reduce the amount of blood a person loses, which is particularly helpful for patients who have broken their hip.

What is already known about the treatment

Tranexamic acid - This medication is an antifibrinolytic drug that is administered directly into a vein through an intravenous injection. It is widely used in medical practice to help prevent or reduce excessive bleeding during surgeries or after injuries. At a molecular level, it works by blocking the proteins that normally break down blood clots, thereby helping the body maintain these clots to stop bleeding.

Investigated diseases

Hip fracture - A hip fracture is a break in the upper part of the femur, which is the large bone in the thigh. This injury typically occurs near the hip joint where the femur meets the pelvis. The condition often develops suddenly due to a physical impact or a fall. In some cases, it can progress through a weakening of the bone structure over time. The break can result in significant pain and a loss of the ability to move the leg or bear weight.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519349-31-00Protocol code2020_TRANEXAMICOEstimated enrolment644 patientsSponsorAsociacion Instituto Biogipuzkoa

sourced from the EU Clinical Trials Register and site verification

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