RecruitingPHASE2INTERVENTIONAL

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

This study is investigating if a medicine called Romiplostim can help patients with low numbers of platelets in their blood (a condition called thrombocytopenia) have heart surgery more safely. Platelets are tiny cells that help blood clot. When you have too few, there's a higher risk of bleeding during surgery. Heart surgery is often life-saving, but having low platelets can make it risky. Romiplostim has shown promise in other areas, and researchers hope it could make it safer for these patients to get the heart surgery they need. Patients in the study will be carefully looked after before and after surgery to monitor their health.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Nantes University Hospital

Enrolment target

136

Start

01 Sep 2026

Estimated completion

01 Dec 2028

Chirurgical Intervention Thrombocytopaenia

What is this study about?

This research study is about a medicine called Romiplostim, which is known by its brand name, Nplate. It's being tested in people who need heart surgery but have a condition called thrombocytopenia. This means they have a lower-than-normal number of platelets in their blood. Platelets are really important because they help your blood clot and stop bleeding. Having too few can make procedures like heart surgery more risky because of the increased chance of bleeding.

Heart surgery is often a very important, even life-saving, procedure. The aim of this study is to see if giving Romiplostim before surgery can boost a patient's platelet count enough to make these crucial heart operations safer for people who currently can't have them easily due to low platelets. If successful, this medicine could open up options for more patients to get the heart surgery they need.

The study also mentions something called "Patient Blood Management" strategies, which usually focus on managing low red blood cell counts (anaemia) before surgery. If this study shows that Romiplostim effectively helps with low platelets, it would add another important tool to help doctors prepare patients for major surgeries, making these operations safer and more accessible for those who need them most. The researchers believe the potential benefits of this study outweigh any risks, as patients will be closely monitored.

Key takeaways

The study tests Romiplostim (Nplate) for low platelets before heart surgery.
Aims to make vital heart operations safer for more patients.
Closely monitors patients before and after surgery.
Could expand options for preparing patients for major surgery.
Participation involves careful medical observation.

Who may be eligible?

This study is looking for adult patients of any age who are planning to have heart surgery. To be included, your surgery must involve using a heart-lung machine (cardiopulmonary bypass), and you must have a platelet count of less than 150,000 before your operation. Your surgery also needs to include a special system that collects and reuses your own blood, and you must be able to receive the study medicine (or a dummy medicine) between 10 and 14 days before your surgery.

However, there are reasons why you might not be able to join. For example, if you can't get the first dose of medicine within 10 days of surgery, or if your heart surgery doesn't use a heart-lung machine. You also can't join if you have certain problems with blood clots, a history of strokes or specific heart attacks, or if you have certain blood cancers. Your doctor will carefully check all these points with 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 an adult with no upper age limit?
Are you scheduled for heart surgery using a heart-lung machine?
Do you have a platelet count strictly below 150,000?
Will your surgery use a blood recovery system (Cell Saver type)?
Can you temporarily stop any antiplatelet medicines before surgery?
Do you have any history of blood clots or strokes?

Answer every question to see your result.

What does participation involve?

If you join this study, you will stay in the hospital within 15 days before you receive your first dose of the study drug (either Romiplostim or a placebo, which is an inactive dummy medicine). You will have your surgery as planned. After your operation, you will be very carefully looked after by doctors and nurses, and they will check your health and blood tests regularly for at least 10 days. The total duration of your participation will involve this period of close monitoring around your surgery, ensuring any side effects are quickly noticed and managed. Specific details about follow-up appointments after you leave the hospital would be discussed with you by the study team.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of making life-saving heart surgery safer for you by improving your platelet count. All participants will be closely watched by medical staff before, during, and after surgery, which means any health changes can be quickly spotted and dealt with. As with any medical treatment or surgery, there are potential risks, and taking new medication always carries the possibility of unexpected side effects. However, the study team believes the potential for you to have your essential heart surgery safely outweighs these potential risks. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (8)

CHU d'Angers
Verified postcode
Angers, France· Not yet recruiting
CHU de Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHU de Brest
Verified postcode
Brest, France· Not yet recruiting
CHU de Dijon
Verified postcode
Dijon, France· Not yet recruiting
CHU de Nantes
Verified postcode
Nantes, France· Recruiting
Hôpital Bichat (AP-HP)
Verified postcode
Paris, France· Not yet recruiting
CHU de Rennes
Verified postcode
Rennes, France· Not yet recruiting
CHU de Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting

Common questions

What are platelets?

Platelets are tiny parts of your blood that help it to clot and stop bleeding. Having enough platelets is crucial, especially during surgery.

What is Romiplostim (Nplate)?

Romiplostim is a medicine that helps your body produce more platelets. It's already used for other conditions and is being studied here for heart surgery.

Why is this study important?

This study aims to make heart surgery safer for people who have low platelet counts, allowing more patients to get the essential operations they need.

Will I know if I'm getting Romiplostim or a placebo?

No, in this type of study (Phase 2), neither you nor your doctors will know if you're receiving the actual medicine or a dummy medicine. This helps ensure fair results.

How long will I be monitored after surgery?

You will be closely monitored with clinical checks and blood tests for at least 10 days after your heart surgery.

How to find out more

Jean- Christophe RIGAL

jeanchristophe.rigal@chu-nantes.fr +33 240165304 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.