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Hematological PatientsPhase 2FORMATNCT05091684

Administration of Fibrinogen Concentrate for Refractory Bleeding

A Phase 2 study testing Fibrinogen Concentrate Human in people with Hematological Patients and Bleeding, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Platelet transfusions are widely employed to prevent or treat bleeding episodes in patients with thrombocytopenia. Patients with bone marrow failure secondary to haematological malignancy and chemotherapy frequently receive prophylactic platelet transfusion when platelet level reaches 10x109.L-1, to avoid spontaneous… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fibrinogen Concentrate Human
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteFrance
Study dates
10 Feb 2022to 27 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient affiliated to a social security regimen or beneficiary of the same
  • Signed written informed consent form
  • Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy, autologous stem cell transplantation or allogeneic stem cell transplantation
  • Grade ≥ II hemorrhagic symptoms according to WWorld Health Organization classification
  • Failure or impossibility to use Human Leucocyte Antigen-matched platelet unit
  • Body weight between 38 and 78 Kgs
  • Transfusion refractoriness as defined by Corrected count increment ≤ 5 and platelet level < 20.109.L-1

Who cannot join

  • Pregnant women
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
  • Refusing participation
  • Patient presenting non-malignant hematological disease
  • Patient with high plasmatic concentration of fibrinogen (>5g/L)
  • Patient who received fibrinogen within 20 days before inclusion
Show all 15Show fewer
  • Contra-indication to fibrinogen (fibrinogen concentrate) or any excipient (fibrinogen concentrate)
  • Patient with disseminated intravascular coagulopathy
  • Patient with thromboembolic history
  • Patient who received L-Asparaginase or acquired hypofibrinogenemia following treatment by L-Asparaginase
  • Patient with known risk of thrombophilia (deficiency for antithrombin 3, C protein or factor V)
  • Patient with anti-thrombotic treatment (anti-platelet or anti-coagulant therapy) at the time of enrolment
  • Elevated body temperature ≥ 38.5°C
  • Hospital stay for invasive surgery
  • Patient with acute myeloid leukemia during the induction phase of chemotherapy.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

Official title: Administration of Fibrinogen Concentrate for Refractory Bleeding in Hematological Patients With Intensive Chemotherapy-induced Thrombocytopenia - Analysis Using Viscoelastic Haemostatic Assay (FORMAT)

Platelet transfusions are widely employed to prevent or treat bleeding episodes in patients with thrombocytopenia. Patients with bone marrow failure secondary to haematological malignancy and chemotherapy frequently receive prophylactic platelet transfusion when platelet level reaches 10x109.L-1, to avoid spontaneous major bleeding. Due to immune or nonimmune factors, platelet refractoriness may be observed and is defined as a repeated suboptimal response to platelet transfusions with lower-than-expected post-transfusion count increments. The management of patients with alloimmunization is complex and prophylactic platelet support is no longer indicated. Therefore, platelet refractoriness remains a clinically challenging complication.

Read the detailed description

To date, no specific therapeutic strategy has been proposed for platelet refractoriness, in cancer patients who are both at high risk of bleeding and thrombosis. Interestingly, fibrinogen is a critical hemostatic protein required for both prevention and treatment of bleeding as it provides a matrix and mesh network essential for clot formation, amplification and strength. Fibrinogen repletion, primarily with the use of fibrinogen concentrates for acquired bleeding, has been reported in clinical settings including surgery, trauma, and obstetrics. However, its use as adjuvant therapy for patients requiring massive transfusion is not yet a widely approved indication, especially in hematological patients. Therefore, the evidence regarding timing, efficacy and safety of fibrinogen administration in massively transfused hematological patients is scarce. This study aims at evaluating whether fibrinogen administration to transfused and refractory patients with on-going bleeding could affect the viscoelastic test of clotting function.

Being tested
Fibrinogen Concentrate Human
Keywords
hematology, intensive chemotherapy, platelet transfusion, thrombocytopenia, fibrinogen
Medical subject headings
Hemorrhage, Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fibrinogen Concentrate HumanDrug

    Refractory transfused patients who present grade ≥ 2 hemorrhagic symptoms will receive a single injection of fibrinogen concentrate (1.5g) followed by platelet transfusion within 2 hours. Blood sampling will be done at different time points to measure clot viscoelasticity: at baseline, after fibrinogen injection, after platelet transfusion and the day after transfusion or before the next platelet transfusion if < 24 hours.

Study groups in NCT05091684
Study groupRoleWhat they receive
FibrinogenExperimentalPatients with refractory thrombocytopenia, following intensive chemotherapy, and presenting grade ≥ 2 hemorrhagic symptoms, will receive adjuvant fibrinogen administration and platelet transfusions.
Receives: Drug: Fibrinogen Concentrate Human

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal clot elasticity (viscoelastic test of clotting function)

    Measurement of viscoelastic test of clotting function represented by the maximal clot elasticity based on the maximal clot firmness from the EXTEM (EXtrinsically activated test) curve, between blood sampling before fibrinogen administration and blood sampling after platelet transfusion

    Measured: 3 hours

Secondary outcomes (5)

  1. Comparison of viscoelastic test of clotting function before and after treatment using EXTEM (EXtrinsically activated test) and FIBTEM (fibrin clot obtained by platelet inhibition with cytochalasin D) curves (Fibrinogen)

    Measurement of viscoelastic test of clotting function to determine the contribution of fibrinogen in clotting (before fibrinogen, after fibrinogen, after fibrinogen + platelet transfusion)

    Measured: 24 hours

  2. Comparison of viscoelastic test of clotting function before and after treatment using EXTEM (EXtrinsically activated test) and FIBTEM (fibrin clot obtained by platelet inhibition with cytochalasin D) curves (platelets)

    Measurement of viscoelastic test of clotting function to determine the contribution of platelets in clotting (baseline, after fibrinogen + platelet transfusion)

    Measured: 24 hours

  3. Comparison of viscoelastic test of clotting function before and after treatment using EXTEM (EXtrinsically activated test) and FIBTEM (fibrin clot obtained by platelet inhibition with cytochalasin D) curves (platelets)

    Measurement of viscoelastic test of clotting function and comparison depending on platelet characteristics

    Measured: 24 hours

  4. Incidence of hemorrhagic and thrombotic events

    Proportions of patients experiencing bleeding and thrombotic events

    Measured: 2 months

  5. Incidence of adverse events

    Proportions of patients experiencing adverse events

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start10 Feb 2022
  3. Primary completion25 May 2023
  4. Study completion27 Jun 2023

Why it stopped: Only one patient was included in this study due to overly restrictive inclusion and exclusion criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05091684
Sponsor's protocol ID
2021-0201
Other IDs
2021-000990-10
Acronym
FORMAT
Status last verified
Dec 2025
First submitted
13 Oct 2021
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fibrinogen Concentrate Human in people with Hematological Patients and Bleeding, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Only one patient was included in this study due to overly restrictive inclusion and exclusion criteria.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal clot elasticity (viscoelastic test of clotting function) (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05091684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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