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Bleeding breakthrough fizzles: fibrinogen trial for chemo patients halted after just one patient

NCT ID NCT05091684

Disease control Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single injection of fibrinogen concentrate followed by a platelet transfusion in blood cancer patients with severe bleeding who did not respond to standard platelet transfusions. The goal was to see if it improved blood clotting. However, the trial was terminated early after enrolling only one participant, so no meaningful conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fibrinogen concentrate
What this could lead to
If it worked, this could offer a way to manage severe bleeding in patients who don't respond to platelet transfusions.
What could go wrong
The trial was terminated early with only 1 participant, so there is very little data. It is unclear if the approach is safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Feb 2022

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

hematologic disorder hematopoietic and lymphoid system neoplasm Hemorrhage hemorrhagic disease thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleeding Hematological patients Platelet refractoriness

Contacts and locations

Locations

  • CHU de Saint-Etienne

    Saint-Etienne, 42055, France

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