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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

FORMAT Study : Use of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion - evaluation by rotem viscoelastometry (pilot single-center study).

This research, called the FORMAT Study, is testing a new way to help patients with blood cancer who are experiencing bleeding. These patients sometimes have a low number of platelets, which are cells that help blood clot, and standard platelet transfusions don't always stop the bleeding. The study is investigating how giving a medicine called fibrinogen, which is important for forming strong blood clots, alongside platelet transfusions, affects how well their blood clots. Doctors will use a special test to measure how firm blood clots become before and after giving these treatments. The main goal is to see if this combination treatment can make blood clot more effectively and reduce bleeding in these vulnerable patients.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Centre Hospitalier Universitaire De Saint Etienne
Enrolment target
10
Start
29 Aug 2024

What is this study about?

This study is called the FORMAT study, and it's looking into better ways to help people with blood cancer who are bleeding. People with blood cancer often have problems with their blood not clotting properly, especially after strong chemotherapy treatments. This happens because chemotherapy can lower the number of 'platelets,' which are tiny blood cells essential for stopping bleeding. When patients bleed, doctors often give them platelet transfusions, but sometimes these don't work as well as hoped.

This study is testing a specific medicine called fibrinogen, which is a protein naturally found in your blood that's crucial for forming strong blood clots. Researchers want to see if giving fibrinogen alongside platelet transfusions can make the blood clot more effectively in patients where standard transfusions haven't been enough. They will use a special test that shows how quickly and strongly blood clots form, measuring this before and after giving the treatments.

The main aim is to find out if this combined approach can improve blood clotting and ultimately reduce serious bleeding in these patients. It's a 'pilot' study, which means it's a smaller, early-stage study to see if this approach is promising enough to be studied in more detail later on. This could potentially lead to better ways to manage bleeding complications for people with blood cancer.

Key takeaways

  • Tests a new way to stop bleeding in blood cancer patients.
  • Uses fibrinogen medicine with platelet transfusions.
  • Aims to improve blood clotting ability.
  • Focuses on patients not responding to standard platelet transfusions.
  • A pilot study to see if this approach is effective.

Who may be eligible?

To join this study, participants need to be adults, meaning they must be 18 years old or older. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to participate in this study. The main requirement for joining is that you have a blood cancer and are experiencing bleeding, and that your blood isn't clotting well even after receiving standard platelet transfusions.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of blood cancer?
  3. Are you currently experiencing bleeding?
  4. Have you received a platelet transfusion recently that hasn't fully stopped your bleeding?
Answer every question to see your result.

What does participation involve?

This is a pilot study, so it involves closely monitoring your blood clotting. Doctors will take blood samples at different times: before you receive the fibrinogen medicine, and then again after you've had both the fibrinogen and platelet transfusions. These blood samples will be used for special tests to see how your blood is clotting. The study will also track if you have any bleeding or clotting problems and collect information about any side effects you might experience. We will also look at how quickly treatments are given after bleeding is noticed. The total duration of your participation would depend on your treatment plan and how long you are being monitored, but it focuses on the immediate effects of the treatments.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination of fibrinogen and platelet transfusion helps your blood clot more effectively, which could reduce bleeding. However, as with any medical treatment, there are potential risks, such as allergic reactions to the medications, or side effects related to blood transfusions, although these are closely monitored. The study will also track blood clots (thrombotic events) as a possible risk. Please remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What kind of patients is this study for?

This study is for adult patients with blood cancer who are bleeding and whose blood isn't clotting well, even after having platelet transfusions.

What is fibrinogen?

Fibrinogen is a natural protein in your blood that is vital for forming strong blood clots to stop bleeding.

What does a 'pilot study' mean?

A pilot study is a small, early-stage study designed to investigate if a new treatment approach is promising enough to be studied in more detail later on.

Will I receive new medicine in this study?

You might receive a medicine called CLOTTAFACT, which is a specific type of fibrinogen, in addition to standard platelet transfusions.

How will doctors know if the treatment is working?

Doctors will take blood samples and use a special test to measure how well your blood is clotting before and after the treatments.

How to find out more

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

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