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Study on the Effectiveness of Human Coagulation Factor IX and Drug Combination for Patients with Major Bleeding on Factor Xa Inhibitor Therapy

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 a treatment for patients experiencing acute major bleeding while on a specific type of blood thinner known as a direct oral anticoagulant (DOAC) that works by inhibiting factor Xa. The treatment being tested is called OCTAPLEX, which is a four-factor prothrombin complex concentrate. This treatment contains several important proteins, including human coagulation factors IX, II, VII, and X, as well as protein C and protein S. These proteins are essential for blood clotting and are used to help reverse the effects of the blood thinner in emergency situations.

The purpose of the study is to evaluate the effectiveness of OCTAPLEX in stopping major bleeding in patients who are taking a factor Xa inhibitor. Participants in the study will receive different doses of OCTAPLEX to determine which dose is more effective in managing the bleeding. The study will involve monitoring patients for a short period after receiving the treatment to observe any changes in their condition and to ensure their safety.

Throughout the study, researchers will assess the treatment's ability to control bleeding and will also monitor for any side effects or complications. The study aims to provide valuable information on how to best manage bleeding in patients taking DOACs, ultimately improving care for those who experience this serious condition.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria. This includes being on oral factor Xa inhibitor therapy and having a certain level of anti-factor Xa activity.

    Written informed consent is required, either from the patient or a legally authorized representative.

  2. Step 2

    Treatment administration

    The treatment involves the administration of Octaplex, a four-factor prothrombin complex concentrate.

    The dosage is determined by body weight, with two possible doses: 50 IU per kilogram or 15 IU per kilogram.

    The medication is given through an intravenous infusion, which means it is delivered directly into a vein.

  3. Step 3

    Monitoring and follow-up

    After receiving the treatment, monitoring occurs for 48 hours to observe any changes in vital signs and laboratory parameters.

    The effectiveness of the treatment is assessed by measuring the change in thrombin generation, a process that helps blood clot.

    The occurrence of any adverse events is recorded during this period.

  4. Step 4

    Evaluation of outcomes

    The primary outcome is the effectiveness of Octaplex in managing major bleeding events.

    Secondary outcomes include changes in thrombin potential, the rate of thromboembolic events, and overall mortality within 30 days.

Who can join the trial?

5 criteria

  • Patients must be taking a medication called a **factor Xa inhibitor**. This is a type of blood thinner that helps prevent blood clots.
  • Patients should have a known or suspected level of **anti-factor Xa activity** of at least 100 ng/mL. This is a measure of how much the medication is affecting the blood's ability to clot.
  • Patients must be 18 years of age or older.
  • Patients or their legally authorized representative must provide written informed consent. This means they agree to participate in the study after being informed about it.
  • Patients must have **acute major bleeding**, which means serious bleeding that could be life-threatening or is not controlled. This includes bleeding in important areas like the brain, spine, eyes, stomach, or muscles, or a significant drop in **hemoglobin** levels, which is a measure of red blood cells in the blood.

Who cannot join the trial?

6 criteria

  • Patients who are not experiencing **acute major bleeding**. This means sudden and severe bleeding.
  • Patients who are not currently receiving **DOAC therapy**. DOACs are a type of medication that helps prevent blood clots.
  • Patients who are not using a **factor Xa inhibitor**. This is a specific type of DOAC that works by blocking a protein involved in blood clotting.
  • Patients who are not in the specified age range for the study.
  • Patients who are not part of the clinical trial group being studied.
  • Patients who are not considered part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or complications.
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Investigated drugs

OCTAPLEX is a medication used in this study to help stop major bleeding in patients who are taking certain blood thinners known as direct oral anticoagulants (DOACs) that work by inhibiting factor Xa. It is a type of prothrombin complex concentrate that contains four different clotting factors. The study aims to see how effective OCTAPLEX is at reversing the effects of these blood thinners in emergency situations.

What is already known about the treatment

Octaplex – Octaplex is administered intravenously and is used in emergency situations to reverse the effects of certain blood thinners, specifically direct oral anticoagulants (DOACs) that inhibit factor Xa. It is currently being studied in clinical trials to assess its effectiveness in managing acute major bleeding in patients on these medications. The main therapeutic indication for Octaplex is to provide rapid reversal of anticoagulation in cases of severe bleeding. At the molecular level, it works by supplying the body with clotting factors that are reduced by DOACs, thereby restoring the blood's ability to clot. Octaplex is classified as a prothrombin complex concentrate, which is a type of medication used to manage bleeding disorders.

Investigated diseases

Acute Major Bleeding in Patients Receiving DOAC Therapy with Factor Xa Inhibitor – This condition occurs when a patient taking direct oral anticoagulants (DOACs) that inhibit factor Xa experiences significant bleeding. Factor Xa inhibitors are medications that prevent blood clots by blocking a specific protein involved in the clotting process. In some cases, these medications can lead to severe bleeding, which is considered a medical emergency. The bleeding can occur in various parts of the body, such as the gastrointestinal tract or brain, and may require immediate medical intervention. The progression of this condition involves the continuation of bleeding, which can lead to further complications if not managed promptly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515485-14-00Protocol codeLEX-210Estimated enrolment230 patientsSponsorOctapharma AG

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