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Study on Tranexamic Acid and Sodium Chloride for Patients with Stroke-Related Brain Bleeding

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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 on a type of stroke known as IntraCerebral Haemorrhage (ICH). ICH is a condition where there is bleeding inside the brain, which can happen suddenly and is often very serious. The purpose of the study is to see if tranexamic acid can help reduce early deaths in patients who have experienced this type of stroke.

Participants in the study will receive either tranexamic acid or a placebo, which is a substance that looks like the medication but does not have any active ingredients. The study will involve giving the treatment through an injection or infusion, which means the medication is delivered directly into the bloodstream. The study will monitor the effects of the treatment on early death within the first seven days after the stroke and also look at how it affects the patient's ability to live independently six months later.

The trial aims to determine if tranexamic acid should be used in regular medical practice for treating ICH. By participating in this study, researchers hope to gather important information that could improve treatment options for people who suffer from this type of stroke in the future.

The research process

The trial runs in 4 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, eligibility is confirmed. This includes being an adult aged 18 or older, having a spontaneous brain bleed confirmed by brain imaging, and presenting within 4.5 hours of the onset of symptoms.

    Informed consent is required, ensuring understanding of the study and agreement to participate.

  2. Step 2

    Initial treatment

    The treatment involves the administration of tranexamic acid, a medication used to help reduce bleeding. It is given as a solution for injection or infusion.

    The specific dosage and frequency of administration are determined by the medical team based on individual needs.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring occurs to assess the effect of the treatment on early death within 7 days after the onset of the brain bleed.

    Follow-up assessments are conducted to evaluate the impact of the treatment on dependency 6 months after the brain bleed.

  4. Step 4

    Completion of the study

    The study aims to determine the effectiveness of tranexamic acid in clinical practice for treating brain bleeds.

    The study is expected to conclude by June 2028, with all data collected and analyzed to understand the treatment's impact.

Who can join the trial?

6 criteria

  • Adults aged 18 years or older.
  • Arrive at the hospital within 4.5 hours after the start of a sudden bleeding in the brain, known as an acute spontaneous intracerebral hemorrhage (ICH).
  • Have the bleeding in the brain confirmed by a brain scan.
  • If the time when symptoms started is unknown, the patient must be within 4.5 hours of when the symptoms were first noticed and meet all other criteria.
  • Patients who are taking direct oral anticoagulants (a type of medication that prevents blood clots) can participate.
  • Provide informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

7 criteria

  • Patients who have had a **stroke** caused by bleeding in the brain.
  • Patients who are not within the age range of 18 to 65 years old.
  • Patients who are not able to give their own consent to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients with severe medical conditions that might interfere with the study.
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Investigated drugs

Tranexamic Acid (TXA) is a medication used in this clinical trial to help reduce bleeding in the brain, which is known as an intracerebral hemorrhage. When a person experiences this type of bleeding, it can be very dangerous and lead to serious health problems or even death. Tranexamic Acid works by helping the blood to clot more effectively, which can slow down or stop the bleeding. The goal of using this medication in the trial is to see if it can help reduce the risk of early death after such a bleeding event. By understanding its effects, researchers hope to determine if Tranexamic Acid should be used regularly in medical practice for patients who experience this kind of brain bleed.

What is already known about the treatment

Tranexamic Acid – Tranexamic acid is administered orally or intravenously and is used to help reduce bleeding. It is currently being studied in clinical trials for its effectiveness in treating patients who have experienced a stroke due to a type of bleeding in the brain called intracerebral hemorrhage. The main therapeutic indication for tranexamic acid in this context is to prevent early death within seven days after the bleeding event. At the molecular level, tranexamic acid works by blocking the breakdown of blood clots, which helps to stabilize the clot and reduce bleeding. It is classified pharmacologically as an antifibrinolytic agent.

Investigated diseases

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can happen due to a blocked artery (ischemic stroke) or the leaking or bursting of a blood vessel (hemorrhagic stroke). In the case of a hemorrhagic stroke, bleeding occurs inside or around the brain, which can lead to increased pressure on the brain tissue. As the condition progresses, brain cells begin to die, which can result in loss of function in the affected areas of the brain. Symptoms may include sudden numbness, confusion, trouble speaking, or difficulty walking. The progression of a stroke can lead to long-term disability depending on the severity and the area of the brain affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500587-35-01Protocol code21022Estimated enrolment5 945 patientsSponsorUniversity Of Nottingham

sourced from the EU Clinical Trials Register and site verification

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