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Study on Heparin and Nadroparin Calcium for Patients Undergoing ECMO Treatment to Reduce Bleeding Risks

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 patients who are receiving a treatment called extracorporeal membrane oxygenation (ECMO). ECMO is a life-support technique used for patients with severe heart and lung problems. The study is investigating two different types of blood thinners, also known as anticoagulants, to see if they can reduce the risk of major bleeding without increasing the risk of blood clots. The two medications being studied are Heparin and Nadroparin Calcium. Heparin is given through a vein, while Nadroparin Calcium is given as an injection under the skin.

The purpose of the study is to find out if using lower doses of these blood thinners can help reduce complications for patients on ECMO. The study will compare the effects of these medications on bleeding, blood clots, and overall survival. Patients will be monitored for up to six months to see how they respond to the treatment. The study aims to improve the safety and effectiveness of ECMO therapy by finding the best way to use these blood thinners.

Participants in the study will receive either Heparin or Nadroparin Calcium, and some may receive a placebo. The study will track various outcomes, including the need for blood transfusions, quality of life, and any complications related to blood clots. By the end of the study, researchers hope to have a clearer understanding of how to best manage anticoagulation in patients undergoing ECMO treatment.

The research process

The trial runs in 6 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. This includes being an adult receiving extracorporeal membrane oxygenation (ECMO) treatment at an intensive care unit (ICU) of a participating center.

  2. Step 2

    Treatment initiation

    The study involves two types of anticoagulation treatments: unfractionated heparin (UFH) and low molecular weight heparin (LMWH). The goal is to reduce anticoagulation targets to minimize major bleeding without increasing the risk of blood clots or affecting outcomes negatively.

  3. Step 3

    Medication administration

    The medications used are heparin and nadroparin calcium. Heparin is administered intravenously, while nadroparin is given through subcutaneous injection. The specific dosage and frequency are determined by the medical team based on individual needs.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, monitoring for major bleeding, thromboembolic complications, and overall health is conducted. This includes checking for events like hemorrhagic stroke, ischemic stroke, limb ischemia, and pump failure.

  5. Step 5

    Outcome evaluation

    Primary outcomes include the occurrence of major bleeding, severe thromboembolic complications, and mortality at six months. Secondary outcomes involve blood transfusions, quality of life assessments, and other health-related parameters.

  6. Step 6

    Trial completion

    The trial is expected to conclude by March 1, 2025. Final assessments will be made to determine the effectiveness and safety of the reduced anticoagulation targets.

Who can join the trial?

4 criteria

  • Must be an adult. This means you need to be 18 years or older.
  • Must be receiving ECMO treatment at the Intensive Care Unit (ICU) of one of the participating centers. ECMO is a machine that helps your heart and lungs work better when they are not doing well on their own.
  • Both men and women can participate.
  • Cannot be part of a vulnerable population. This means you should not be in a group that needs special protection, like children or people who cannot make decisions for themselves.

Who cannot join the trial?

1 criterion

  • Patients who are receiving ECMO treatment only to support a procedure like a high-risk heart procedure or during surgery cannot participate.
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Investigated drugs

  • Unfractionated Heparin (UFH)

    is a medication used to prevent and treat blood clots. In this trial, it is being used with reduced anticoagulation targets to see if it can lower the risk of major bleeding while still preventing clots effectively during extracorporeal life support.

  • Low Molecular Weight Heparin (LMWH)

    is another type of blood thinner used to prevent and treat blood clots. This trial is testing if using LMWH can reduce the occurrence of major bleeding without increasing the risk of clotting problems, compared to the standard practice of using UFH with higher anticoagulation targets.

What is already known about the treatment

  • Unfractionated Heparin (UFH)

    This medication is administered intravenously and is commonly used in hospitals to prevent blood clots. In the context of the clinical trial, UFH is being studied for its effectiveness in reducing major bleeding events when used with lower anticoagulation targets during extracorporeal membrane oxygenation (ECMO) therapy. UFH works by inhibiting certain factors in the blood clotting process, thus preventing clot formation. It is classified as an anticoagulant and is well-documented in medical literature for its use in various clotting disorders.

  • Low Molecular Weight Heparin (LMWH)

    This medication is typically administered via subcutaneous injection and is used to prevent and treat blood clots. In the clinical trial, LMWH is being evaluated for its potential to reduce major bleeding without increasing thromboembolic complications during ECMO therapy. LMWH acts by inhibiting specific clotting factors, similar to UFH, but with a more predictable response and longer duration of action. It is also classified as an anticoagulant and is widely recognized in medical literature for its safety and efficacy in managing clotting conditions.

Investigated diseases

  • Hemorrhagic Stroke

    This condition occurs when a blood vessel in the brain bursts, leading to bleeding in or around the brain. The bleeding can cause pressure on brain tissues, leading to damage. Symptoms may include sudden severe headache, weakness, confusion, or difficulty speaking. As the condition progresses, it can lead to further neurological impairments. The severity and progression depend on the location and extent of the bleeding. Immediate medical attention is crucial to manage the condition effectively.

  • Ischemic Stroke

    This type of stroke happens when a blood clot blocks or narrows an artery leading to the brain, reducing blood flow. The lack of blood flow causes brain cells to begin dying within minutes. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or loss of balance. The progression can lead to significant neurological deficits if not promptly addressed. The extent of damage depends on the duration and location of the blockage. Early intervention is key to minimizing long-term effects.

  • Limb Ischemia

    This condition arises when there is a severe reduction in blood flow to a limb, often due to a blockage in the arteries. It can cause pain, numbness, or weakness in the affected limb. As it progresses, it may lead to tissue damage or even gangrene if blood flow is not restored. The severity of symptoms can vary based on the extent of the blockage and the duration of reduced blood flow. Prompt medical treatment is essential to prevent permanent damage.

  • Acute Pump Failure

    This occurs when a mechanical pump, such as those used in ECMO therapy, fails to function properly. It can lead to inadequate circulation of blood and oxygen throughout the body. Symptoms may include sudden drop in blood pressure, reduced oxygen levels, or signs of organ dysfunction. The progression of this condition can be rapid and requires immediate intervention to restore proper circulation. The underlying cause of the pump failure needs to be addressed to prevent recurrence.

  • Pulmonary Embolism

    This condition is characterized by a blockage in one of the pulmonary arteries in the lungs, usually due to blood clots that travel from the legs or other parts of the body. Symptoms can include sudden shortness of breath, chest pain, and coughing. As the condition progresses, it can lead to reduced oxygen levels in the blood and strain on the heart. The severity depends on the size and number of clots. Quick medical intervention is crucial to manage the condition effectively.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509675-16-01Estimated enrolment330 patientsSponsorUniversitair Medisch Centrum Groningen

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