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A study of tranexamic acid to reduce blood loss during hip surgery in children with hip dysplasia and other hip conditions

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What is this trial about?

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

This study focuses on several conditions affecting the hip in children, including Slipped Capital Femoral Epiphysis, Legg-Calvé-Perthes Disease, and Developmental Dysplasia of the Hip. These conditions may require surgical procedures involving the hip bone. During such operations, blood loss can occur, which is what this study aims to address.

The study will test whether a medication called tranexamic acid can help reduce the amount of blood lost during hip surgery in children. Some patients will receive tranexamic acid through an injection into their vein, while others will receive a placebo with saline solution. The medication or placebo will be given before the surgery starts.

The surgical procedures involved in this study are proximal femoral osteotomy and pelvic osteotomy, which are operations where surgeons make controlled cuts in the hip bones to improve their position and function. During the study, doctors will measure how much blood is lost during surgery and monitor the patients' recovery. This will help determine if tranexamic acid is effective in reducing blood loss during these types of hip surgeries in children.

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

    Initial treatment preparation

    Your participation begins with preparation for hip surgery. This surgery is called proximal femoral and/or pelvic osteotomy, which means making controlled cuts in the hip bone to improve its position.

    Before the surgery, you will be randomly assigned to receive either tranexamic acid (a medication that helps control bleeding) or saline (salt water solution) through an intravenous injection.

  2. Step 2

    Pre-operative procedures

    Medical staff will take blood samples to measure your baseline blood values, including hemoglobin (a protein that carries oxygen in your blood).

    The medical team will record your basic health information and medical history, including any previous surgeries in the same area.

  3. Step 3

    Surgery day

    You will receive the assigned medication (either tranexamic acid or saline) through an intravenous line before the surgery begins.

    During the surgery, the medical team will monitor and record the amount of blood loss.

    If needed, additional medications to control bleeding may be administered during the procedure.

  4. Step 4

    Post-operative monitoring

    After surgery, medical staff will take blood samples to check your blood values again.

    The medical team will monitor for any complications and record if any blood transfusions are needed.

    Your hospital stay duration will be documented as part of the study data.

  5. Step 5

    Study completion

    The study concludes after your hospital discharge and final blood tests.

    All collected data will be used to evaluate how effective tranexamic acid is in reducing blood loss during hip surgery.

Who can join the trial?

10 criteria

  • Patient must be between 1 and 18 years old
  • Patient must need a hip bone surgery that involves either:
    • Surgery of the upper part of the thigh bone (proximal femoral osteotomy), or
    • Surgery of the hip socket (pelvic osteotomy), or
    • Both types of surgery together
    • The surgery can be needed for any medical reason, including:
      • Slipped growth plate in the hip
      • Hip joint development problems
      • Muscle and nerve conditions affecting the hip
      • Both male and female patients can participate
      • Patient must be scheduled for surgery at the study hospital
      • Patient's parent or legal guardian must agree to participation if the patient is under the age of consent

Who cannot join the trial?

14 criteria

  • Patients with a history of blood clotting disorders (conditions that affect how blood forms clots)
  • Those currently taking anticoagulation medications (blood-thinning drugs)
  • Known allergic reactions to tranexamic acid (TXA) or similar medications
  • Active bleeding disorders or significant bleeding risks
  • Severe kidney problems (as TXA is cleared through the kidneys)
  • History of seizures or epilepsy
  • Current urinary tract bleeding
  • Patients with color vision deficiency (as this may affect monitoring)
  • Those who received blood transfusions within the last 3 months
  • Children with severe liver disease
  • Patients with uncontrolled high blood pressure
  • Those participating in other clinical trials
  • Inability to comply with study follow-up requirements
  • Lack of parent/guardian consent for study participation
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Investigated drugs

  • Tranexamic acid (TXA)

    is a medication that helps reduce bleeding during surgery. It works by preventing blood clots from breaking down too quickly, which helps control blood loss. This medication is given before surgery and is particularly useful in orthopedic procedures like hip surgeries. It's a well-established medication that has been used safely in both adults and children to manage surgical bleeding.

  • Placebo

    is an inactive substance that contains no medication. It's used as a comparison to measure how effective the real medication (tranexamic acid) is at reducing blood loss during surgery.

What is already known about the treatment

Tranexamic acid (TXA) – A synthetic drug administered intravenously before surgery to reduce blood loss during surgical procedures. It works by blocking the breakdown of blood clots, making it an effective antifibrinolytic agent that helps maintain blood clotting during operations. This medication belongs to the class of hemostatic agents and is particularly valuable in orthopedic surgeries, including hip osteotomies in pediatric patients. TXA has been extensively studied in clinical trials and is well-documented in medical literature as an effective tool for reducing surgical bleeding, particularly in procedures where significant blood loss is expected.

Investigated diseases

  • Slipped capital femoral epiphysis (SCFE)

    A hip condition where the upper end of the thigh bone (femoral head) slips backward off the neck of the bone. This condition typically occurs during periods of rapid growth in adolescence. The slip develops gradually over time and can affect one or both hips.

  • Legg-Calvé-Perthes Disease (LCPD)

    A childhood hip disorder that affects the head of the femur. The condition occurs when blood supply to the hip joint is temporarily interrupted, causing the bone cells to die. Over time, the bone gradually reforms, but may heal in an abnormal shape.

  • Neuromuscular conditions

    A group of disorders that affect the functioning of muscles and their control by the nervous system. These conditions can cause muscle weakness, movement problems, and impair normal joint development. The conditions can affect various parts of the body including the hips.

  • Secondary hip dysplasia

    A condition where the hip joint develops abnormally as a result of another underlying medical condition or previous trauma. The hip socket may be too shallow or incorrectly shaped, leading to improper fit of the hip joint.

  • Developmental dysplasia of the hip (DDH)

    A condition present from birth where the hip joint hasn't formed normally. The ball part of the joint may be loose in the socket or may be completely dislocated. This condition can affect one or both hips and ranges from mild to severe.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516324-34-01Estimated enrolment180 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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