AuthorisedTherapeutic exploratory (Phase II)Interventional

Low-dose versus standard-dose anticoagulation with argatroban or enoxaparin during extracorporeal membrane oxygenation controlled by anti-IIa or anti-Xa assay

This study is comparing two common blood-thinning medicines, argatroban and enoxaparin, for patients who are very unwell and need an ECMO machine to help their heart and/or lungs. The main goal is to find the best and safest dose of these medicines. We're looking at whether a lower dose or a standard dose causes fewer problems like bleeding or harmful blood clots. The researchers will carefully check how well these medicines work and if they cause any side effects. This research aims to improve care for patients on ECMO by making sure they receive the right amount of blood thinner.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fakultni Nemocnice Ostrava

Enrolment target

200

Start

19 Mar 2026

lung and/or heart failure

What is this study about?

When someone's heart or lungs are very sick and can't do their job properly, doctors sometimes use a special machine called ECMO (Extracorporeal Membrane Oxygenation). This machine acts as an artificial heart and lung, taking over their work so the body can rest and heal. While on ECMO, blood needs to be kept flowing smoothly through the machine without clotting. To do this, patients are given medicines called 'blood thinners' or 'anticoagulants'.

This study is comparing two different blood-thinning medicines, argatroban and enoxaparin, and also looking at different doses – a lower dose versus a standard dose. The main thing the doctors want to find out is which dose of these medicines is the safest and most effective for patients on ECMO. They are especially interested in preventing two main problems: blood clots, which can be very dangerous, and too much bleeding, which can also be harmful.

The researchers will closely monitor how these medicines work in the body, checking things like blood tests and looking for any signs of bleeding or clotting. They want to understand how the amount of medicine in the blood relates to these problems. This research is important because it could help doctors choose the best blood-thinning treatment for future patients on ECMO, making their care safer and more effective.

Key takeaways

This study is for very ill patients needing ECMO life support.
It compares two common blood-thinning medicines at different doses.
The goal is to find the safest and most effective dose to prevent clots and bleeding.
Patients' blood will be closely monitored.
Participation could improve future care for ECMO patients.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old. There is no upper age limit for joining. The study is open to both men and women.

Critically, you would also need to be a patient who requires support from an ECMO machine because your heart or lungs are not working well enough on their own.

Your medical team would review your overall health and specific medical situation to determine if this study is suitable and safe for you to participate in, as there might be other specific reasons why you couldn't join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you currently receiving ECMO support for heart or lung failure?
Has your doctor discussed this study with you?
Are you able to speak with the medical team about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the study's blood-thinning medicines – either argatroban or enoxaparin – at either a low dose or a standard dose, as decided by the study doctors. These medicines are given through an infusion (a drip) or injection while you are on the ECMO machine.

The research team would regularly check your blood through routine blood tests. These tests help them understand how the medicine is working in your body and make sure you are receiving the right amount. They would also carefully monitor you for any signs of bleeding or blood clots.

Your participation would continue for as long as you need ECMO support, and the study team would follow your progress throughout your treatment in the hospital. All assessments and measurements are part of your hospital stay and care.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of how best to use blood-thinning medications for patients on ECMO, which could help improve care for many people in the future. For you personally, the study aims to find the safest and most effective dose, potentially reducing your risk of blood clots or severe bleeding. However, there are no guarantees of direct personal benefit. Potential risks are primarily related to the blood-thinning medications themselves, which can include an increased risk of bleeding (from minor bruises to serious internal bleeding) or, less commonly, clotting. The study team will monitor you very closely to manage these risks. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is ECMO?

ECMO is a special machine that takes over the job of your heart and lungs when they are too sick to work on their own, allowing your body to rest and heal.

What are blood thinners?

Blood thinners are medicines that help prevent blood clots from forming, which is important when your blood is flowing through an ECMO machine.

Will I know which medicine or dose I'm getting?

The study aims to compare treatments, so you might not know if you're getting the low or standard dose, or which specific medicine, but the doctors will always prioritize your safety.

Will this study interfere with my normal care?

No, this study is designed to integrate with your ongoing medical care. The treatments and monitoring are part of your overall hospital management while on ECMO.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect the quality of your medical care.