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Study on the Effect of Tranexamic Acid to Reduce Bleeding in Patients on Blood Thinners After Pacemaker Surgery

Registered 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 patients who have a pacemaker and are taking a blood-thinning medication called acenocoumarol. The study is investigating the use of a medication called tranexamic acid, which is applied directly to the skin, to see if it can help reduce bleeding and bruising after the pacemaker is implanted. Tranexamic acid is known for its ability to help control bleeding.

The purpose of the study is to evaluate whether using tranexamic acid can effectively reduce the risk of bleeding and bruising in these patients. Participants in the study will receive either the tranexamic acid treatment or a placebo, and the effects will be compared. The study will also look at other factors such as the risk of infection, the length of the hospital stay, and whether there is a need for additional treatments like blood transfusions or other medications to help stop bleeding.

Throughout the study, participants will be monitored to ensure their safety and to gather information on how well the treatment works. The study aims to provide valuable insights into managing bleeding risks for patients who need a pacemaker and are on blood thinners, potentially improving care for these individuals 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

    Joining the study

    Participation begins after providing consent and confirming eligibility. Eligibility includes being over 18 years old, undergoing pacemaker implantation, and receiving anticoagulant therapy with acenocoumarol.

  2. Step 2

    Pacemaker implantation

    The procedure involves the implantation of a permanent pacemaker. This is a medical device that helps regulate the heartbeat.

  3. Step 3

    Application of <b>tranexamic acid</b>

    After the pacemaker implantation, tranexamic acid is applied topically. This medication is used to reduce bleeding and bruising. It is administered as a solution for injection but used on the skin in this trial.

  4. Step 4

    Monitoring and evaluation

    The primary focus is on evaluating any bleeding or bruising that occurs after the pacemaker implantation. The effect of tranexamic acid in reducing these events is assessed.

    Secondary evaluations include checking for infections, the duration of the procedure, length of hospital stay, need for blood products, use of additional medications to stop bleeding, and any clotting issues.

  5. Step 5

    Follow-up

    Regular follow-up appointments are scheduled to monitor health and any side effects. The trial is expected to continue until February 2027.

Who can join the trial?

5 criteria

  • Patients must be undergoing a procedure to have a **permanent pacemaker** implanted. A pacemaker is a small device placed in the chest to help control the heartbeat.
  • Patients must be over **18 years of age**.
  • Patients must give their **consent** to participate in the study. This means they agree to be part of the study after understanding what it involves.
  • Patients must be receiving **anticoagulant therapy** with a medication called **acenocoumarol** before the procedure. Anticoagulant therapy involves taking medicine to prevent blood clots.
  • Both **male and female** patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who are not taking blood-thinning medication called acenocoumarol.
  • Patients who have not had a pacemaker implanted.
  • Patients who are not experiencing bleeding or bruising issues after pacemaker implantation.
  • Patients who are not within the age range specified for the study.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care.
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Investigated drugs

  • Tranexamic Acid (TXA)

    is used in this trial to evaluate its ability to reduce bleeding and bruising in patients who are on blood thinners and have had a pacemaker implanted. It is applied topically, meaning it is placed directly on the skin where the pacemaker was implanted, to help control bleeding.

  • Acenocoumarol

    is a medication that patients in this trial are already taking. It is a type of blood thinner used to prevent blood clots. The trial is studying how tranexamic acid can help manage bleeding in patients who are taking acenocoumarol and have undergone pacemaker implantation.

What is already known about the treatment

Tranexamic Acid – Tranexamic Acid is administered topically and is currently being studied in a clinical trial to assess its effectiveness in reducing bleeding in patients who have pacemakers and are on anticoagulant therapy. It is widely recognized in medical literature for its role in controlling bleeding. The main therapeutic indication for Tranexamic Acid in this trial is to prevent hemorrhage and hematoma formation in patients taking anticoagulants like acenocoumarol. At the molecular level, Tranexamic Acid works by inhibiting the activation of plasminogen to plasmin, a molecule responsible for breaking down blood clots, thus helping to stabilize clots and reduce bleeding. It is classified pharmacologically as an antifibrinolytic agent.

Investigated diseases

  • Hemorrhage

    Hemorrhage refers to the escape of blood from a ruptured blood vessel, which can occur internally or externally. It can result from injury, surgery, or certain medical conditions. The severity of hemorrhage can vary, ranging from minor bleeding to significant blood loss. In anticoagulated patients, the risk of hemorrhage may increase due to the blood's reduced ability to clot. This condition requires careful monitoring to prevent excessive blood loss.

  • Hematoma

    A hematoma is a localized collection of blood outside of blood vessels, usually in liquid form within the tissue. It often occurs due to an injury or trauma that causes blood vessels to break. Hematomas can vary in size and may cause swelling, pain, and discoloration of the skin. In some cases, they may resolve on their own, while in others, they may require medical intervention. Hematomas can occur in various parts of the body, including under the skin, in muscles, or within organs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520929-20-00Protocol codeHTAJ-TRANEX-2019-01Estimated enrolment100 patientsSponsorHospital Universitario Tajo

sourced from the EU Clinical Trials Register and site verification

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