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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Universitario Araba Vitoria Spain
Hmbttrrs Upncklqylqnvy Dcjbfdug Donostia / San Sebastian Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.03.2023

Trial locations

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.

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 ID:
2024-519349-31-00
Protocol code:
2020_TRANEXAMICO
NCT ID:
NCT05489185
Trial Phase:
Therapeutic confirmatory (Phase III)

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