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Study on Tranexamic Acid and Sodium Chloride for Reducing Blood Loss in Patients Undergoing Burn Surgery

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 a medication called tranexamic acid during surgery for patients with burn injuries. Burn injuries can cause significant damage to the skin and underlying tissues, and sometimes surgery is needed to remove damaged tissue. The purpose of this study is to see if tranexamic acid can help reduce the amount of blood loss during these surgeries and to understand how the body breaks down blood clots during the procedure.

In this study, participants will receive either tranexamic acid or a placebo during their surgery. Tranexamic acid is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Another solution, sodium chloride, which is commonly known as salt water, may also be used in the study. The study will monitor the volume of blood loss and the body's process of breaking down blood clots, known as fibrinolysis, during the surgery.

The study aims to gather information on whether tranexamic acid can effectively reduce the need for blood transfusions and improve surgical outcomes for patients undergoing burn surgery. The research will also look at other factors such as the success of skin grafts, which are used to cover and heal the burn area, and any complications that may arise during or after the surgery. This information will help doctors understand the potential benefits of using tranexamic acid in burn surgeries and improve care for patients with burn injuries.

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, participation is confirmed for individuals scheduled for burn excisional surgery with an expected blood loss of at least 250 ml. This estimation is based on factors such as the percentage of body surface area to be excised, the surgical technique used, and the time elapsed since the burn injury.

  2. Step 2

    Preparation for surgery

    Before the surgery, preparation involves understanding the objectives of the study, which are to assess whether tranexamic acid reduces blood loss and the need for blood transfusions, and to evaluate the extent of fibrinolysis during surgery.

  3. Step 3

    Administration of medication

    During the surgery, tranexamic acid is administered as a solution for injection or infusion. This medication is given intravenously, meaning it is delivered directly into a vein. The specific dosage and frequency are determined by the medical team based on individual needs.

    Additionally, a sodium chloride solution may be used for infusion to maintain fluid balance during the procedure.

  4. Step 4

    Monitoring during surgery

    Throughout the surgery, monitoring focuses on the volume of blood loss and the extent of fibrinolysis, which is the process that prevents blood clots from growing and becoming problematic.

  5. Step 5

    Post-surgery evaluation

    After the surgery, evaluation includes assessing the need for blood transfusions, the success of the skin graft, and any complications such as cardiopulmonary or neurological issues. The strength of blood clots and fibrin structures is also examined.

  6. Step 6

    Follow-up

    Follow-up involves monitoring the length of hospital stay and overall recovery, including any additional treatments or interventions required.

Who can join the trial?

4 criteria

  • Patients must be scheduled for **burn excisional surgery**. This is a type of surgery where damaged skin from a burn is removed.
  • The expected **blood loss** during the surgery should be **250 milliliters or more**. This is based on the surgeon's estimation considering factors like the size of the burn area, the technique used in surgery, and how long it has been since the burn injury.
  • Patients must be **18 years old or older**.
  • Both **male and female** patients can participate.

Who cannot join the trial?

4 criteria

  • Patients who have a **burn injury** cannot participate in the study. A burn injury is damage to the skin or other tissues caused by heat, chemicals, electricity, or radiation.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who do not meet the gender requirements for the study cannot participate. The study is open to both male and female participants.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.
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Investigated drugs

Tranexamic Acid is a medication used in this clinical trial to see if it can help reduce the amount of blood loss during surgery for burn patients. It is also being studied to determine if it can decrease the need for blood transfusions. Tranexamic acid works by helping to prevent the breakdown of blood clots, which can help control bleeding during and after surgery.

What is already known about the treatment

Tranexamic Acid – This medication is typically administered orally or intravenously, depending on the specific medical needs. It is currently well-established in medical literature and is used in various clinical settings. The main therapeutic indication for tranexamic acid is to reduce bleeding, particularly during surgeries or in conditions where excessive bleeding is a concern, such as burn injuries. At the molecular level, tranexamic acid works by inhibiting the activation of plasminogen to plasmin, an enzyme involved in the breakdown of blood clots, thereby reducing fibrinolysis and stabilizing clots. It is classified pharmacologically as an antifibrinolytic agent.

Investigated diseases

Burn Injury – A burn injury is damage to the skin or other tissues caused by heat, chemicals, electricity, sunlight, or radiation. The severity of a burn is determined by its depth and the extent of the body affected. Burns can be classified into first, second, or third degree, with first-degree burns affecting only the outer layer of skin and third-degree burns extending through all layers of skin and possibly affecting underlying tissues. As the burn progresses, it can lead to swelling, blistering, and in severe cases, charring of the skin. Healing from a burn injury can involve the formation of scars and may require skin grafts for severe cases. The body's response to a burn can also include inflammation and increased risk of infection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513573-49-00Estimated enrolment95 patientsSponsorMaasstad Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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