Not yet recruitingOBSERVATIONAL

Pilot Study to Establish a Repertoire of Megakaryocyte Markers, Quantifiable by Spectral Flow Cytometry, in Bone Marrow and Circulating in Patients Undergoing Cardiac Surgery for Bypass Grafting

This study aims to understand how our bodies make special cells called megakaryocytes, which are responsible for producing blood platelets that help stop bleeding. These cells are particularly important during heart bypass surgery, a time when the body experiences stress and inflammation, which can affect how platelets are made. Currently, doctors can only look at these cells under a microscope. However, newer techniques could give a more detailed picture. This research will use a special method called flow cytometry to study megakaryocytes from blood and bone marrow samples taken before, during, and after heart bypass surgery. The goal is to see if there are different types of these cells and how they behave during surgery to help improve our understanding of healing and recovery.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Toulouse

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jul 2027

Cardiac Surgery for Bypass Grafting

What is this study about?

Imagine your body's a factory, and your blood platelets are tiny repair crews that rush to fix any leaks. These platelets are made by bigger 'parent' cells called megakaryocytes, mostly located in your bone marrow. This study is like taking a closer look at that factory, specifically focusing on how these parent cells behave around the time of heart bypass surgery. We know that surgery, especially heart bypass, can be a major event for your body, causing inflammation and changes in how your blood clots.

Currently, doctors mainly rely on a simple look under a microscope to understand these megakaryocyte cells. But new technologies, like a special type of blood test called flow cytometry, offer a much more detailed view. This study wants to use this advanced technology to get a clearer picture of megakaryocytes, not just in the bone marrow but also those that might be circulating in your bloodstream, before, during, and after heart bypass surgery.

The main aim is to understand if there are different kinds of megakaryocytes and how they change or adapt when your body is under the stress of surgery. This knowledge could help us better understand how your body responds to surgery, heals, and processes inflammation, potentially leading to better care in the future. Heart bypass surgery gives us a unique opportunity to study these processes because it's a planned procedure where we can safely collect samples.

Key takeaways

Aims to understand how blood-clotting cells are made during heart surgery.
Uses advanced blood tests to get a detailed look at these special cells.
Involves collecting blood and a small bone marrow sample during your surgery.
Could help improve future care for patients undergoing heart surgery.
No new treatments are given; it's an observational study.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, who is scheduled for heart bypass surgery involving an opening in the chest (sternotomy). You'll also need to have current social security coverage and be able to understand what the study involves.

There are several reasons you might not be able to take part. For example, if you are pregnant or breastfeeding, or if you have certain blood disorders like leukaemia or lymphomas. You also can't join if you are receiving treatment with certain medications that affect blood cells or inflammation, if you've had a recent organ or stem cell transplant, or if you have active cancer.

Other reasons for not being able to participate include if your heart surgery is not planned in advance, if you've had similar chest surgery before, if you've had radiotherapy to your chest, or if you are under legal protection (like guardianship). If you're already in another clinical trial that requires blood or bone marrow samples, or if you are receiving palliative care, you also won't be able to join this study.

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 for heart bypass surgery that involves opening your chest?
Are you not pregnant or breastfeeding?
Do you not have certain serious blood disorders or active cancer?
Are you not on treatment with certain medications (like anti-inflammatories or blood cell activators)?
Have you not had a recent organ or stem cell transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to provide blood samples at several different times: before your surgery, during the surgery itself, and after the surgery. You will also have a small sample of bone marrow taken during your heart surgery. This is a common procedure during this type of surgery.

There are no additional clinic visits specifically for this study. All samples will be collected during your standard hospital stay for your heart bypass surgery. You won't be given any special medications for this study; it's purely observational, meaning researchers are just looking at existing processes. The total duration of your participation will cover the period around your surgery and immediate recovery in the hospital.

Potential risks and benefits

The main benefit of taking part in this study is that you would be contributing to a better understanding of how the body responds to heart surgery and inflammation, which could help improve patient care in the future. There are no direct medical benefits to you personally. The risks involved are mainly linked to the blood and bone marrow samples. Blood draws can cause minor bruising or discomfort. The bone marrow sample is collected during your heart surgery, so it won't involve a separate procedure, but it carries the usual small risks associated with any bone marrow collection, such as temporary pain or a very small risk of infection. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Toulouse University Hospital
Verified postcode
Toulouse, France

Common questions

What are megakaryocytes?

They are special cells primarily in your bone marrow that produce tiny blood cells called platelets, which help your blood to clot.

Why is this study focused on heart bypass surgery?

Heart bypass surgery is a significant event for the body, causing stress and inflammation, making it a good time to study how platelet-making cells respond.

Will I receive any new treatments in this study?

No, this is an observational study. You will not receive any new treatments or medications. Researchers are just studying your body's natural processes.

What exactly will be done to me for this study?

You'll have blood samples taken at different times and a small bone marrow sample collected during your heart surgery.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study whenever you wish, and it will not affect your medical care.

How to find out more

Agnès Ribes

ribes.a@chu-toulouse.fr +33(0)5.61.32.28.36 Official trial record

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