Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Comparing low-dose and standard-dose argatroban or enoxaparin to prevent blood clots in patients with heart or lung failure receiving extracorporeal membrane oxygenation.

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is intended to compare different ways of preventing blood clots in patients receiving Extracorporeal Membrane Oxygenation, which is a method used to support the function of the heart and lungs by circulating blood through an external machine. The conditions being studied are Heart Failure and Lung Failure. Participants will receive treatment with either argatroban or enoxaparin through an intravenous infusion, which is a way of delivering medication directly into a vein. Argatroban and enoxaparin are types of anticoagulants, which are substances used to prevent blood from clotting too much.

The study examines whether using a low dose or a standard dose of these medications is safer and more effective. The amount of medication given will be monitored using specific laboratory tests, such as the anti-IIa assay or the anti-Xa assay, which are methods used to measure how well the blood is being thinned. These tests help ensure that the blood does not become too thick, causing clots, or too thin, which could lead to bleeding.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>administration of anticoagulant medication</b>

    You will receive medication through an intravenous infusion, which means the medicine is delivered directly into a vein.

    The treatment involves using either argatroban monohydrate or enoxaparin sodium to prevent blood clots while receiving extracorporeal membrane oxygenation (ECMO) support. ECMO is a machine that helps your heart and lungs function by pumping and oxygenating your blood outside of your body.

    If argatroban monohydrate is used, the dose is 0.05 mg per kilogram of body weight.

    If enoxaparin sodium is used, the dose is 480 IU per kilogram of body weight.

  2. Step 2

    <b>monitoring and assessment</b>

    The medication levels will be monitored using specific laboratory tests. these tests, known as anti-IIa or anti-Xa assays, measure how well the blood is being thinned to prevent complications like bleeding or thrombotic complications, which are blood clots.

    The effectiveness and safety of the anticoagulation therapy, which is the process of using medicine to prevent blood from clotting, will be observed throughout the treatment period.

Who can join the trial?

5 criteria

  • You must be using ECMO, which is a machine that acts as an artificial heart and lung to help your body pump blood and take in oxygen.
  • You must be receiving anticoagulation treatment, which means you are taking medicine to prevent blood clots from forming.
  • The specific medicines being used for your blood thinning must be argatroban or enoxaparin.
  • You must be 18 years of age or older.
  • You or your legal representative must provide informed consent, which means you have been given all the necessary information about the study and have formally agreed to participate.

Who cannot join the trial?

4 criteria

  • You are currently enrolled in the lung transplant program, which is a specialized medical program for people who need a new lung.
  • You have a known hypersensitivity, which means your body has an abnormally strong or unusual reaction, to any part of the study medications.
  • You have had an allergic reaction, which is an immune system response that can cause symptoms like itching, swelling, or trouble breathing, to the active ingredients in the study medications.
  • You are pregnant or currently breastfeeding.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Argatroban

    is a medication used to prevent blood clots from forming in the bloodstream. In this study, it is being tested to see how well it works to keep blood flowing smoothly while a patient is receiving specialized breathing and heart support.

  • Enoxaparin

    is a type of medicine that thins the blood to help prevent dangerous blood clots. This study investigates its use in helping patients stay safe from clotting while they are on life support machines.

What is already known about the treatment

  • Argatroban monohydrate

    This medication is an injectable liquid administered through an intravenous infusion to help prevent blood clots. It is a known anticoagulant used to treat patients who cannot use standard blood thinners, such as those with low platelet counts. At a molecular level, it works by directly blocking an enzyme called thrombin, which is a key player in the body's process of forming blood clots. This substance belongs to a group of drugs known as direct thrombin inhibitors.

  • Enoxaparin sodium

    This medication is an injectable solution typically given through an intravenous infusion to prevent or treat blood clots. It is widely used in medical practice as a standard treatment to stop dangerous clotting in various conditions. It works by interfering with a specific protein in the blood called factor Xa, which prevents the blood from thickening too much. This drug is classified as a low-molecular-weight heparin.

Investigated diseases

  • Heart failure

    This condition occurs when the heart muscle cannot pump blood as effectively as it should to meet the body's needs. It often develops gradually as the heart becomes weakened or stiff over time. As the condition progresses, the heart may struggle to circulate enough oxygen-rich blood to vital organs. This can lead to a buildup of fluid in the lungs and other parts of the body. The severity can increase as the heart works harder to compensate for its reduced pumping capacity.

  • Lung failure

    This condition happens when the lungs can no longer perform their essential function of transferring oxygen into the blood and removing carbon dioxide. It can result from various underlying issues that damage the lung tissue or the air sacs. As the disease advances, the levels of oxygen in the bloodstream may drop significantly. This progression often leads to increased difficulty in breathing and impaired gas exchange. Over time, the respiratory system becomes increasingly unable to support the body's metabolic requirements.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524553-13-00Estimated enrolment200 patientsSponsorFakultni Nemocnice Ostrava

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.