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Study of romiplostim given before heart surgery in patients with low platelet counts to improve blood clotting after surgery

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What is this trial about?

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

This study involves patients who have a low number of platelets in their blood, a condition known as thrombocytopenia, and who need to have heart surgery. Platelets are small blood cells that help the blood to clot and stop bleeding. When the platelet count is low, there is a greater risk of bleeding during and after surgery. The treatment being tested in this study is romiplostim, which is a medication that helps the body produce more platelets. Some patients will receive romiplostim before their surgery, while others will receive a placebo. The medication will be given as an injection under the skin.

The purpose of this study is to find out if romiplostim given before heart surgery can help reduce the severity of low platelet counts after the surgery compared to placebo. Patients will receive their first injection between 14 and 10 days before their scheduled heart surgery. The study will look at the lowest platelet count that occurs from the end of the heart surgery until seven days after the surgery. The study will also track other factors such as how much bleeding occurs after surgery, whether patients need transfusions of platelets or other blood products, and how patients recover after their operation.

Throughout the study, doctors will monitor platelet counts and other blood measurements at different time points before and after surgery. They will also track any complications that may occur, such as bleeding events, blood clots in veins or arteries, infections, and how long patients need to stay in the intensive care unit and in the hospital. The study will follow patients for up to three months after surgery to assess their overall recovery and any side effects from the treatment. The treatment period with the study medication lasts for 14 days, and patients will receive up to three injections during this time.

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

    First injection of study medication

    Between 14 and 10 days before your scheduled heart surgery, you will receive the first injection of the study medication. This will be either romiplostim (a medication that helps increase platelet counts) or placebo (an inactive substance). The medication will be given as an injection under the skin.

    Neither you nor your medical team will know which treatment you are receiving during the study.

  2. Step 2

    Period before surgery

    After receiving the first injection, you will continue with your preparations for the scheduled heart surgery. This period lasts from the day of the first injection until the day of your operation.

  3. Step 3

    Heart surgery with extracorporeal circulation

    You will undergo the planned heart surgery. The surgery will be performed using extracorporeal circulation, which is a machine that temporarily takes over the function of your heart and lungs during the operation.

    During the surgery, a blood recovery system will be used to collect and return your own blood.

    The day of your surgery is considered day 0.

  4. Step 4

    Monitoring from end of surgery to day 7

    From the end of the surgery until the 7th day after the operation, your platelet count (the number of small blood cells that help with clotting) will be monitored through blood tests. Platelets are measured in number per cubic millimeter of blood.

    The amount of bleeding from surgical drains will be measured at specific times: from closure of the breastbone until 12 hours after surgery, from hospital discharge until 24 hours after surgery, and from 24 hours after surgery until the drains are removed.

    Your blood hemoglobin level (a measure of red blood cells that carry oxygen) will also be monitored.

    If needed, you may receive transfusions of platelet concentrate, red blood cell concentrate, or fresh frozen plasma. You may also receive blood-derived medications such as fibrinogen, prothrombin complex concentrates, or recombinant activated factor VII.

    Your time on mechanical ventilation in the intensive care unit will be recorded.

    Any bleeding events, blood clot formation in veins or arteries, infections, or problems with organ function will be monitored and recorded.

    Blood tests may be performed at the hospital or, if you are discharged before day 7, they may be done outside the hospital.

  5. Step 5

    Extended monitoring until day 28

    Monitoring will continue until the 28th day after your surgery. During this period, your platelet count and hemoglobin levels will continue to be checked.

    Any additional transfusions or blood-derived medications given during this time will be recorded.

    Your length of stay in the intensive care unit and total hospital stay will be documented.

    Any complications, bleeding events, blood clots, infections, or organ problems occurring during this period will be monitored.

  6. Step 6

    Follow-up until 3 months after surgery

    You will be followed for up to 3 months after your surgery to monitor for any bleeding events, blood clots in veins or arteries, and infections.

    During the first month after surgery, you will receive medication to prevent blood clots. This will be either medication that prevents platelets from sticking together or medication that prevents blood from clotting, or both types.

Who can join the trial?

6 criteria

  • You must be an adult patient with no upper age limit
  • You must have a scheduled cardiac surgery, which is an operation on your heart, that uses ECC (a machine that temporarily takes over the work of your heart and lungs during surgery)
  • You must have thrombocytopenia before surgery, which means your blood has a low number of platelets (cells that help your blood clot), specifically fewer than 150,000 platelets per cubic millimeter of blood
  • Your surgery must be performed using a centrifugal blood recovery system (a device that collects and cleans blood during surgery so it can be given back to you) or a similar device
  • It must be possible to give you the first injection of the study medication between 14 and 10 days before your surgery
  • Your surgery must require you to take antiaggregant (medication that prevents blood cells from sticking together) or anticoagulant (medication that prevents blood clots) treatment for at least 1 month after the operation

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial in the available information.
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Investigated drugs

Romiplostim is a medication that helps the body make more platelets. Platelets are small blood cells that help stop bleeding by forming clots. This medicine is given before heart surgery to patients who have low platelet counts. The goal is to increase the number of platelets in the blood so that bleeding problems during and after surgery can be reduced.

What is already known about the treatment

Romiplostim – Romiplostim is a medication given as an injection under the skin that stimulates the body to produce more platelets, which are blood cells that help with clotting. It works by mimicking a natural protein called thrombopoietin, which attaches to specific receptors on bone marrow cells and signals them to make more platelets. This medication is approved for treating low platelet counts in certain conditions and is currently being studied in clinical trials to see if it can help patients with low platelet levels who need heart surgery. By increasing platelet numbers before surgery, it may reduce bleeding complications during and after the procedure.

Investigated diseases

Thrombocytopenia – Thrombocytopenia is a condition characterized by an abnormally low number of platelets in the blood. Platelets are small blood cells that help the blood to clot and stop bleeding. When platelet counts drop below normal levels, the blood's ability to clot properly is reduced. This can lead to increased bleeding and bruising, even from minor injuries. The condition can range from mild to severe depending on how low the platelet count becomes. In patients undergoing cardiac surgery, thrombocytopenia can complicate the surgical procedure and recovery period due to increased bleeding risk.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517710-15-00Protocol codeRC24_0458Estimated enrolment136 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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