Using fibrinogen concentrate to treat bleeding in patients with platelet refractoriness
Administration of Fibrinogen Concentrate for Refractory Bleeding in Hematological Patients With Intensive Chemotherapy-induced Thrombocytopenia - Analysis Using Viscoelastic Haemostatic Assay (FORMAT)
This study is testing if giving fibrinogen concentrate can help patients with low platelet counts who are bleeding and haven't responded to platelet transfusions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Saint-Étienne) |
| Trial ID | NCT05091684 on ClinicalTrials.gov |
What this trial studies
This study evaluates the administration of fibrinogen concentrate in hematological patients experiencing refractory bleeding due to low platelet counts. It focuses on patients undergoing intensive chemotherapy or stem cell transplantation who have not responded adequately to platelet transfusions. The goal is to determine if fibrinogen can improve clotting function in these patients, potentially addressing a significant clinical challenge. The study will assess the efficacy and safety of fibrinogen administration in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with hematological malignancies undergoing intensive chemotherapy who exhibit platelet refractoriness and have significant bleeding symptoms.
Not a fit: Patients with non-malignant hematological diseases or those with high fibrinogen levels are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce bleeding complications in patients with hematological malignancies who are refractory to platelet transfusions.
How similar studies have performed: While the use of fibrinogen in other clinical settings has shown promise, its application for platelet refractoriness in hematological patients is relatively novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint-Étienne
- CHU de Saint-Etienne — Saint-Étienne, France (Recruiting)
Study contacts
- Principal investigator: Emilie Chalayer, MD, PhD — CHU de Saint-Etienne
- Study coordinator: Emilie Chalayer, MD, PhD
- Email: emilie.chalayer@chu-st-etienne.fr
- Phone: 0477917089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.