AuthorisedTherapeutic exploratory (Phase II)Interventional

Preoperative use of Romiplostim in thrombocytopenic patients undergoing cardiac surgery. A Phase 3, multicenter randomized double-blinded controlled against placebo study

This research study is about a new approach for patients who have low platelet counts and need heart surgery. Platelets are tiny blood cells that help your blood clot. People with low platelet counts can be at higher risk of bleeding during and after surgery. This study is testing a medication called Nplate to see if it can safely increase platelet levels before surgery, potentially reducing bleeding and the need for blood transfusions. Some patients will receive Nplate, while others will receive a placebo (a dummy treatment, like salt water) – neither the patient nor the doctor will know which one they are getting. Doctors will closely monitor platelet counts and any need for blood products for up to 28 days after the operation to understand how effective Nplate is.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

136

Start

22 Oct 2025

thrombocytopenic patients undergoing cardiac surgery

What is this study about?

This study is looking into a new treatment called Nplate for people who have low platelet counts and are preparing for heart surgery. Platelets are really important because they help your blood clot, which stops you from bleeding too much if you get a cut or have an injury. If your platelet count is too low, there's a higher chance of bleeding during and after a major operation like heart surgery.

The main goal of this study is to see if giving Nplate before heart surgery can help to raise a patient's platelet count and reduce the amount of bleeding they experience. The researchers also want to find out if Nplate can lower the need for blood transfusions (receiving donated blood products) during and after the operation. This is important because transfusions, while often necessary, can sometimes have their own risks.

To make sure the results are reliable, patients will be randomly assigned to receive either Nplate or a placebo. A placebo is a substance that looks exactly like the study drug but doesn't contain any active medicine – in this case, it's a salt water solution. This is a common way to test new medicines, as it helps doctors understand if any changes are truly due to the drug and not other factors. Neither you nor your doctors will know which treatment you are receiving until the study is over. The study will pay close attention to your platelet levels, any bleeding, and your recovery for a few weeks after the surgery.

Key takeaways

This study is for adults with low platelets who need heart surgery.
It tests a drug called Nplate to boost platelet levels before surgery.
The aim is to reduce bleeding and the need for blood transfusions.
Participants will receive Nplate or a dummy treatment (placebo).
Close monitoring will occur for up to 28 days after surgery.

Who may be eligible?

This study is looking for adults who are getting ready for heart surgery and have a low number of platelets in their blood. Platelets are special blood cells that help your blood clot and stop bleeding.

To join, you need to be at least 18 years old. Both men and women can take part. The medical team will check other specific health details to make sure the study is a safe and good fit for you.

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 18 years old or older?
Are you scheduled to have heart surgery?
Do you have a low platelet count?
Are you happy to be monitored for up to 28 days after your operation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study drug (Nplate) or a placebo (a dummy treatment) before your heart surgery. This will be given as an injection. Your medical team will regularly check your blood, especially your platelet counts, from the time before your surgery, during the operation, and for up to 28 days afterwards. They will also keep a close eye on any bleeding, and whether you need blood transfusions or other blood-related medicines. You will have regular checks and assessments to monitor your health and recovery both in the hospital and potentially after you go home, up to 28 days post-surgery. The total duration of active follow-up for this study is approximately one month after your operation.

Potential risks and benefits

Potential benefits of taking part might include improved platelet counts, which could lead to less bleeding and a reduced need for blood transfusions during and after heart surgery. However, as this is a research study, there's no guarantee you will personally benefit. Potential risks could include side effects from the study drug (if you receive it) or from the procedures and monitoring involved, though these will be carefully explained by your doctors. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual 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
France

Common questions

What are platelets and why are they important?

Platelets are tiny cells in your blood that help it to clot. They are very important for stopping bleeding, especially during surgery.

What is Nplate?

Nplate is a medicine being tested in this study. It's designed to help your body make more platelets.

What is a placebo?

A placebo is a 'dummy' treatment, like a salt water injection, that looks like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine.

Will I know if I'm getting Nplate or the placebo?

No, neither you nor your doctors will know if you are receiving Nplate or the placebo. This is to ensure the study results are as accurate as possible.

How long will I be monitored after surgery?

You will be closely monitored for your platelet levels, bleeding, and recovery for up to 28 days after your heart surgery.