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Study of Fibrinogen Treatment for Bleeding in Patients with Blood Cancer and Low Platelet Count Who Do Not Respond to Platelet Transfusions

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with hematological malignancy who experience bleeding problems after receiving intensive chemotherapy. These patients have low blood platelet counts and do not respond well to standard platelet transfusions. The study will test a treatment that combines human fibrinogen (a protein that helps blood clot) with platelet transfusions to help control bleeding.

The treatment being studied is called CLOTTAFACT, which contains human fibrinogen and is given through an intravenous injection. The purpose of the study is to see if adding fibrinogen to platelet transfusions can improve blood clotting in patients whose bodies don't respond well to platelet transfusions alone. The study will measure how well the blood clots before and after receiving the combined treatment.

During the study, patients will receive fibrinogen followed by a platelet transfusion. Blood samples will be taken at different times to measure how well the treatment works. The study will also track any bleeding events or other health issues that occur during the treatment period. The amount of fibrinogen given will be based on the patient's body weight, with a maximum single dose of 1.5 grams.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your blood sample will be taken for the first ROTEM test (a special blood clotting measurement)

    The medical team will evaluate your bleeding symptoms according to the WHO classification

  2. Step 2

    First treatment phase

    You will receive an intravenous injection of fibrinogen (CLOTTAFACT)

    A second blood sample will be taken for ROTEM testing

  3. Step 3

    Second treatment phase

    You will receive a platelet transfusion

    A third blood sample will be taken for ROTEM testing

  4. Step 4

    Monitoring phase

    The medical team will monitor you for any bleeding or blood clotting events

    Regular blood tests will continue to check your blood count and clotting status

    Any side effects will be recorded and monitored

  5. Step 5

    Follow-up assessments

    Your response to the treatment will be evaluated through continued monitoring

    The medical team will assess the effectiveness of the treatment based on your ROTEM test results and bleeding symptoms

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Must have a blood cancer (malignant hemopathy) that requires either:
    • intensive chemotherapy
    • stem cell transplantation from yourself (autologous)
    • stem cell transplantation from a donor (allogeneic)
    • Must have bleeding symptoms rated as grade 1 or higher according to WHO classification
    • Must have a condition where:
      • platelet transfusions are not working effectively
      • or specially matched (HLA-matched) platelets cannot be given
      • Body weight must be between 38 and 78 kilograms
      • Must have a low platelet count that doesn't improve sufficiently after transfusions (measured by Corrected Count Increment)
      • Both men and women can participate

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Presence of any blood clotting disorders not related to blood cancer
  • Known allergies to blood products or fibrinogen (a protein that helps blood clot)
  • Active severe infection
  • Severe liver disease that affects blood clotting
  • Recent major surgery (within the last 30 days)
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • History of severe reactions to blood transfusions
  • Presence of antibodies (immune system proteins) that could interfere with platelet transfusions
  • Severe kidney disease requiring dialysis
  • Active bleeding in the brain
  • Unstable heart condition
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Investigated drugs

  • Fibrinogen

    is a protein naturally present in the blood that helps with blood clotting. In this trial, it is used as a medication to help control bleeding in patients who have low platelet counts due to chemotherapy. The medication is given alongside platelet transfusions to help improve blood clotting in patients whose bodies don't respond well to platelet transfusions alone.

  • Platelet transfusion

    is a medical procedure where platelets from donated blood are given to patients. Platelets are tiny blood cells that help form blood clots to stop bleeding. In this trial, platelet transfusions are used to treat patients who have low platelet counts due to intensive chemotherapy treatment for blood-related cancers.

What is already known about the treatment

Fibrinogen - A blood-clotting protein administered intravenously to treat bleeding in patients with low platelet counts who have not responded well to platelet transfusions. This medication is primarily used in hematological malignancy patients who have undergone intensive chemotherapy and are experiencing bleeding complications. Fibrinogen works at the molecular level by converting to fibrin, which creates a mesh-like structure that helps form blood clots and stop bleeding. This medication belongs to the pharmacological class of hemostatic agents and is particularly valuable in managing bleeding when standard platelet transfusions prove ineffective, with its effectiveness monitored through viscoelastometric testing methods.

Investigated diseases

Hematological Malignancy - A group of blood-related cancers that begin in blood-forming tissue, such as bone marrow, or in cells of the immune system. This condition affects the production and function of blood cells, including red blood cells, white blood cells, and platelets. The disease can lead to decreased blood cell counts, affecting the body's ability to fight infections, carry oxygen, and form blood clots. Patients may experience fatigue, frequent infections, easy bruising, and bleeding problems. The condition can progress at different rates depending on the specific type of blood cancer involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516494-73-00Protocol code2021-0201Estimated enrolment10 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

sourced from the EU Clinical Trials Register and site verification

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