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Study on Anticoagulation Strategies with Heparin, Enoxaparin, and Argatroban for Patients with Respiratory or Circulatory Failure on ECMO Support

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 different treatment strategies for patients who need support from a machine called Extracorporeal Membrane Oxygenation, or ECMO. ECMO is used in serious conditions like Respiratory Insufficiency, Respiratory Failure, Circulatory Failure, and Acute Respiratory Distress Syndrome. The study will compare three medications that help prevent blood clots, which are a common risk during ECMO therapy. These medications are Unfractionated Heparin, Argatroban, and Low-molecular-weight Heparin (also known as Enoxaparin).

The purpose of the study is to see how these medications affect the occurrence of blood clots during ECMO therapy. Participants will be randomly assigned to receive one of the three medications. The study will monitor the incidence of blood clots, such as pulmonary embolism and deep vein thrombosis, as well as any bleeding events. The study will last for a period of up to six months for each participant.

Throughout the study, participants will receive regular check-ups to monitor their health and the effectiveness of the medication they are receiving. The goal is to determine which medication is most effective in preventing blood clots without causing significant bleeding. This information will help improve treatment strategies for patients requiring ECMO support 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, you will be assigned to one of three groups. Each group will receive a different type of medication to help prevent blood clots during a treatment called extracorporeal membrane oxygenation (ECMO).

  2. Step 2

    Medication administration

    If you are in the first group, you will receive heparin sodium through an intravenous infusion. This means the medication will be given directly into your vein.

    If you are in the second group, you will receive enoxaparin sodium through a subcutaneous injection. This means the medication will be injected under your skin.

    If you are in the third group, you will receive argatroban monohydrate through an intravenous infusion, similar to the first group.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes checking for any signs of blood clots or bleeding. Regular imaging tests and sonography (a type of ultrasound) will be used to detect any issues.

    The study aims to compare the effectiveness of the three medications in preventing blood clots during ECMO therapy.

  4. Step 4

    Completion of the study

    The study is expected to continue until March 2027. Your participation will help determine the best medication strategy for patients undergoing ECMO therapy.

Who can join the trial?

3 criteria

  • Patients must be older than 18 years.
  • Patients must be in an Intensive Care Unit (ICU).
  • Patients must either require ECMO support or have started ECMO therapy within the last 12 hours. (ECMO stands for Extracorporeal Membrane Oxygenation, a treatment that uses a machine to take over the work of the lungs and sometimes the heart.)

Who cannot join the trial?

4 criteria

  • Patients with Respiratory Insufficiency cannot participate. This means their lungs are not working well enough to meet the body's needs.
  • Patients with Respiratory Failure are excluded. This is a condition where the lungs cannot provide enough oxygen to the blood or remove enough carbon dioxide from it.
  • Patients with Circulatory Failure cannot join. This is when the heart and blood vessels cannot supply enough blood to the body's organs.
  • Patients with Acute Respiratory Distress Syndrome (ARDS) are not eligible. ARDS is a severe lung condition causing breathing difficulties.
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Investigated drugs

  • Unfractionated Heparin

    is a medication used to prevent blood clots. In this study, it is being used to help patients who are receiving a type of life support called Extracorporeal Membrane Oxygenation (ECMO). This medication works by thinning the blood, which helps to stop clots from forming in the blood vessels.

  • Argatroban

    is another medication used to prevent blood clots. It is different from unfractionated heparin because it directly blocks a protein in the blood that helps clots form. In this study, Argatroban is being tested to see if it is as effective as other medications in preventing clots during ECMO therapy.

  • Enoxaparin

    is a type of low-molecular-weight heparin, which is also used to prevent blood clots. It works similarly to unfractionated heparin but is often given in a different way. In this study, Enoxaparin is being compared to the other medications to see how well it prevents clots in patients on ECMO support.

What is already known about the treatment

  • Unfractionated Heparin

    This medication is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently widely used in medical practice and literature for its role in preventing blood clots. The main therapeutic indications include conditions like respiratory insufficiency, respiratory failure, circulatory failure, and acute respiratory distress syndrome, especially during procedures like extracorporeal membrane oxygenation (ECMO). At the molecular level, unfractionated heparin works by activating a protein in the blood called antithrombin, which then inhibits clotting factors, preventing the formation of clots. It is classified as an anticoagulant, which is a type of medication that helps prevent blood clots.

  • Argatroban

    This medication is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is recognized in medical literature for its use in preventing blood clots, particularly in patients undergoing ECMO therapy. The main therapeutic indications include respiratory insufficiency, respiratory failure, circulatory failure, and acute respiratory distress syndrome. Argatroban works by directly inhibiting thrombin, an enzyme in the blood that is essential for clot formation, thus preventing clots from forming. It is classified as a direct thrombin inhibitor, a type of anticoagulant.

  • Enoxaparin

    This medication is administered subcutaneously, which means it is injected under the skin. It is well-documented in medical literature for its effectiveness in preventing blood clots. The main therapeutic indications include conditions such as respiratory insufficiency, respiratory failure, circulatory failure, and acute respiratory distress syndrome, especially during ECMO therapy. Enoxaparin works by enhancing the activity of antithrombin, a protein in the blood that inhibits clotting factors, thereby preventing clot formation. It is classified as a low-molecular-weight heparin, a type of anticoagulant.

Investigated diseases

  • Respiratory Insufficiency

    This condition occurs when the lungs cannot take in enough oxygen or expel enough carbon dioxide. It can develop slowly over time or suddenly. The body may try to compensate by increasing breathing rate. As it progresses, symptoms like shortness of breath and fatigue become more pronounced. In severe cases, it can lead to confusion or a bluish tint to the skin due to lack of oxygen. It often requires medical intervention to manage effectively.

  • Respiratory Failure

    This is a severe condition where the respiratory system fails to maintain adequate gas exchange. It can be acute or chronic, with acute cases developing rapidly. The body struggles to get enough oxygen or remove carbon dioxide, leading to symptoms like difficulty breathing and confusion. As it progresses, it can cause organ dysfunction due to lack of oxygen. It often requires immediate medical attention to support breathing. Chronic cases may develop over time and require long-term management.

  • Circulatory Failure

    Also known as shock, this condition occurs when the circulatory system fails to supply enough blood to the body's tissues. It can result from various causes, including heart problems or severe blood loss. As it progresses, it can lead to symptoms like rapid heartbeat, low blood pressure, and confusion. The body may try to compensate by constricting blood vessels and increasing heart rate. Without adequate blood flow, organs can become damaged. It requires prompt medical intervention to restore circulation.

  • Acute Respiratory Distress Syndrome

    This is a severe lung condition that occurs when fluid builds up in the air sacs, preventing enough oxygen from reaching the bloodstream. It often develops quickly in response to an injury or infection. As it progresses, it causes severe shortness of breath and low blood oxygen levels. The lungs become stiff, making breathing difficult. It can lead to rapid breathing and a feeling of suffocation. It requires immediate medical care to support breathing and oxygenation.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518702-40-00Estimated enrolment90 patientsSponsorMedical University Of Vienna

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