Administration of Fibrinogen Concentrate for Refractory Bleeding (NCT05091684) | Clinical Trial Compass
TerminatedPhase 2
Administration of Fibrinogen Concentrate for Refractory Bleeding
Stopped: Only one patient was included in this study due to overly restrictive inclusion and exclusion criteria.
France1 participantsStarted 2022-02-10
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal clot elasticity (viscoelastic test of clotting function)
Timeframe: 3 hours
Trial details
NCT IDNCT05091684
SponsorCentre Hospitalier Universitaire de Saint Etienne