Administration of Fibrinogen Concentrate for Refractory Bleeding

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Oct 13, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a treatment called fibrinogen concentrate to help patients with certain types of blood disorders who are experiencing severe bleeding and have difficulty responding to platelet transfusions. Platelet transfusions are often given to patients with low platelet counts, but some patients do not respond well to these transfusions, which can make managing their bleeding more challenging. The trial is looking for patients aged 65 to 74 who have a confirmed blood cancer diagnosis and are undergoing intensive chemotherapy or stem cell transplantation. They must also have significant bleeding symptoms and have not had success with regular platelet transfusions.

Participants in this trial will receive fibrinogen concentrate to see if it can help improve their bleeding symptoms. To be eligible, patients must be able to provide consent and meet specific health criteria, such as having a certain weight and experiencing low platelet levels. However, there are some exclusions, like pregnancy or certain medical conditions that could complicate treatment. This trial is currently recruiting participants, and it's important for anyone considering joining to discuss it with their healthcare team to understand all aspects of the study and what to expect.

Gender

ALL

Eligibility 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.