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Study on Tranexamic Acid Oral Solution for Preventing Bleeding in Patients on Blood Thinners Undergoing Tooth Extraction

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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 prevention of bleeding in patients who are taking blood thinners and need to have one or more teeth removed. The blood thinners involved in this study are known as direct oral anticoagulants and vitamin K antagonists. The treatment being tested is called Tranexamic Acid Oral Solution 5%, which is a liquid medication taken by mouth. The study will compare the effects of this treatment with a placebo to see if it can help reduce bleeding after dental procedures.

The main goal of the study is to find out if Tranexamic Acid Oral Solution 5% can effectively reduce bleeding that is significant enough to be considered clinically important. This includes bleeding in the mouth and face area after having teeth extracted. Participants in the study will be randomly assigned to receive either the tranexamic acid solution or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for any bleeding episodes after their dental procedures. The study will also assess how acceptable the medication is to the participants, which means looking at how easy it is for them to take the medication as directed. The study is expected to last for a short period, with the treatment being given for up to seven days. The results will help determine if Tranexamic Acid Oral Solution 5% is a safe and effective option for managing bleeding in patients on blood thinners undergoing tooth extractions.

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

    Initial visit

    During the initial visit, the patient will receive detailed information about the study and provide informed consent to participate.

    A pregnancy test will be conducted for females of childbearing potential.

    The patient's medical history, physical examination, and vital signs will be assessed to ensure eligibility.

  2. Step 2

    Screening

    The patient will undergo screening to confirm eligibility, including a hemoglobin test and platelet count.

    The patient's body mass index (BMI) and weight will be measured.

    For patients on vitamin K antagonists, an International Normalized Ratio (INR) test will be conducted.

  3. Step 3

    Medication administration

    The patient will be randomly assigned to receive either Tranexamic Acid Oral Solution 5% or a placebo.

    The medication will be administered as an oral solution, following the prescribed dosage and schedule.

  4. Step 4

    Tooth extraction procedure

    The patient will undergo a scheduled single or multiple tooth extraction.

    The procedure will be monitored for any immediate postoperative bleeding.

  5. Step 5

    Postoperative monitoring

    The patient will be observed for any postoperative oral bleeding episodes, both clinically relevant and not clinically relevant.

    The duration of any perioperative and immediate postoperative bleeding will be recorded.

  6. Step 6

    Follow-up visits

    The patient will attend follow-up visits to assess the occurrence of any delayed postoperative bleeding.

    The patient will complete a Medication Acceptability Questionnaire to evaluate the use of the Tranexamic Acid Oral Solution 5%.

Who can join the trial?

14 criteria

  • Provide their signed study informed consent to participate.
  • Have a hemoglobin level of at least 12.0 g/dL for males or at least 11.0 g/dL for females. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Willing to avoid alcohol consumption for the duration of the study.
  • Willing and able to follow the study schedule and other requirements, as shown by signing a written informed consent.
  • For females who can have children, a negative pregnancy test is required at the start of the study and on the first day of the study.
  • Women must be post-menopausal, surgically sterile, or willing to use a highly effective method of birth control. Post-menopausal means not having menstrual periods for 12 months without another medical reason.
  • Be 18 years of age or older at the time of screening.
  • Have a body mass index (BMI) between 18.5 and 35, and weigh at least 50 kg. BMI is a measure of body fat based on height and weight.
  • Have been treated regularly for at least 3 months with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). These are medications that help prevent blood clots.
  • If taking VKAs, the International Normalized Ratio (INR) should be between 2.0 and 3.5 at screening. INR is a test that measures how long it takes for blood to clot.
  • Taking VKAs or DOACs according to the approved product label.
  • Scheduled to have one or more teeth removed.
  • Considered reasonably healthy to follow the study procedures, as shown by medical history, physical examination, and vital sign assessments.
  • Have a platelet count between 100,000 and 500,000 platelets per microliter. Platelets are blood cells that help with clotting.

Who cannot join the trial?

6 criteria

  • Patients who are not taking **direct oral anticoagulants (DOACs)** or **vitamin K antagonists (VKAs)**. These are types of medications that help prevent blood clots.
  • Patients who are not undergoing a single or multiple tooth extraction. This means if you are not having one or more teeth removed, you cannot participate.
  • Patients who are not at risk of clinically relevant bleeding events. This refers to bleeding that could be significant or require medical attention.
  • Patients who are not within the specified age range for the study. The study is looking for participants within certain age groups.
  • Patients who are not part of the specified clinical trial groups. The study is targeting specific groups of people for participation.
  • Patients who are not considered part of a vulnerable population. This means the study is looking for participants who may have certain health conditions or circumstances that make them more vulnerable.
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Investigated drugs

Tranexamic Acid Oral Solution is being studied to see if it can help reduce bleeding after tooth extractions in people who are taking blood thinners. This medication is used to prevent excessive bleeding by helping the blood to clot more effectively. It is given as an oral solution, which means it is taken by mouth in liquid form. The study aims to find out if this solution can safely and effectively reduce the risk of bleeding in patients who are on medications that make them more prone to bleeding, such as direct oral anticoagulants or vitamin K antagonists.

What is already known about the treatment

Tranexamic Acid Oral Solution 5% – This medication is administered orally and is currently being studied in a phase 3 clinical trial. It is used to prevent significant bleeding events in patients who are on blood thinners, such as direct oral anticoagulants or vitamin K antagonists, and are undergoing tooth extractions. Tranexamic Acid works by inhibiting the breakdown of blood clots, helping to maintain hemostasis. It is classified as an antifibrinolytic agent, which means it helps to prevent excessive bleeding by stabilizing clots.

Investigated diseases

Postoperative Oral Bleeding – This condition involves bleeding that occurs after a surgical procedure in the mouth, such as tooth extraction. It can be classified as clinically relevant or not, depending on the severity and impact on the patient. Clinically relevant bleeding may require medical attention and can include the formation of orofacial hematomas. The bleeding can occur early, within 24 hours post-surgery, or be delayed, happening after this period. The condition is particularly monitored in patients who are on anticoagulant medications, as they are at a higher risk of bleeding complications. The progression of postoperative oral bleeding is influenced by factors such as the type of anticoagulant used and the number of teeth extracted.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503719-13-00Protocol codeHYL-P004-003Estimated enrolment338 patientsSponsorHyloris Developments

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