Study on Tranexamic Acid for Reducing Blood Loss in Osteoarthritis Patients Undergoing Total Hip Replacement

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tranexamic Acid in patients with Osteoarthritis who are undergoing surgery for a total hip replacement. Tranexamic Acid is a medicine commonly used to treat and prevent bleeding problems. The study aims to find out if injecting Tranexamic Acid directly into the hip joint during surgery can help reduce the amount of blood loss compared to the usual treatment.

Participants in the study will receive Tranexamic Acid through an injection into their vein at the start of the surgery. Some participants will also receive an injection of Tranexamic Acid directly into the hip joint at the end of the surgery, while others will receive an injection of a harmless saltwater solution, known as a placebo, instead. The main goal is to measure the total blood loss within 24 hours after the surgery.

The study will also look at the total blood loss on the morning of the second day after surgery. This research will help determine if the additional injection of Tranexamic Acid into the joint can provide extra benefits in reducing blood loss during hip replacement surgery for patients with Osteoarthritis.

1 joining the study

Eligibility for participation requires being 18 years or older, undergoing surgery for a single hip replacement, and the ability to provide consent verbally or in writing.

2 pre-surgery preparation

Before the surgery begins, an intravenous (IV) dose of tranexamic acid is administered. This medication is used to help prevent excessive bleeding during the procedure.

3 surgery and medication administration

During the surgery for hip replacement, an additional dose of tranexamic acid is injected directly into the hip joint at the end of the procedure. This is done to further reduce blood loss.

4 post-surgery monitoring

The primary focus is on measuring the total blood loss within the first 24 hours after the surgery. This is a key indicator of the effectiveness of the treatment.

5 follow-up assessment

A secondary assessment of blood loss is conducted on the morning of the second day after the surgery. This helps in understanding the longer-term effects of the treatment.

Who Can Join the Study?

  • Must be 18 years or older.
  • Undergoing surgery for unilateral total hip arthroplasty, which means having a hip joint replaced on one side of the body.
  • Able to give consent, either verbally or in writing, which means you can agree to participate in the study.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Osteoarthritis cannot participate. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a vulnerable population are not excluded, meaning those who are not considered vulnerable can participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Hhkbizpj Hpottcod Hvidovre Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.12.2020

Trial locations

Investigated drugs:

Tranexamic Acid (TXA) is used in this clinical trial to help reduce blood loss during and after total hip replacement surgery. It is administered in two ways: intravenously (IV) at the start of the surgery and directly into the joint at the end of the surgery. The goal is to see if this combination can effectively minimize the total amount of blood lost within 24 hours after the surgery.

Osteoarthritis – Osteoarthritis is a common joint disorder that primarily affects the cartilage, which is the protective tissue at the ends of bones. As the cartilage wears down over time, it can lead to pain, swelling, and reduced motion in the affected joints. The disease often progresses slowly, with symptoms worsening over the years. It most commonly affects joints in the hands, knees, hips, and spine. As the condition advances, bone spurs may develop, and the joint may become stiff and painful. Osteoarthritis is more prevalent in older adults, but it can occur in younger individuals as well, especially if they have experienced joint injuries.

Trial ID:
2024-517398-26-01
Trial Phase:
Therapeutic exploratory (Phase II)

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