BridgeMD
FORMAT Study : Use of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion - evaluation by rotem viscoelastometry (pilot single-center study).
EU CTIS ID: 2024-516494-73-00
What this study is testing
To assess the efficacy of the administration of fibrinogen associated with a platelet transfusion on the relevant visco-elastometric parameters (ROTEM method) in patients with malignant hemopathy, thrombocytopenics, refractory to platelet transfusions, with grade ≥ I hemorrhagic signs according to the WHO - WHO classification, modified according to Slichter.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Major patient
- Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation
- Grade ≥ 1 hemorrhagic symptom according to WHO - WHO classification
- Failure or impossibility of transfusion of HLA-matched platelet concentrates
- Body weight between 38 and 78 kg
- Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI)
You likely can't join if
- Patient who expressed his opposition to participating in the study
- Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant)
- Patients with a thromboembolic history
- Patients treated with L-Asparaginase or with hypofibrinogenemia secondary to L-Asparaginase treatment
- Patient with hyperthermia ≥ 38.5°C
- Patient hospitalized for an invasive procedure
See the full eligibility criteria
- Major patient
- Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation
- Grade ≥ 1 hemorrhagic symptom according to WHO - WHO classification
- Failure or impossibility of transfusion of HLA-matched platelet concentrates
- Body weight between 38 and 78 kg
- Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI)
- Patient who expressed his opposition to participating in the study
- Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant)
- Patients with a thromboembolic history
- Patients treated with L-Asparaginase or with hypofibrinogenemia secondary to L-Asparaginase treatment
- Patient with hyperthermia ≥ 38.5°C
- Patient hospitalized for an invasive procedure
- Patients with acute leukemia during the induction chemotherapy phase
- Pregnant or breastfeeding woman
- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
- Patient with non-malignant hematological involvement
- Patient with a high plasma fibrinogen concentration (> 5g / L)
- Patients who received fibrinogen administration within 20 days prior to study entry
- Patient allergic to fibrinogen
- Patient with disseminated intravascular coagulopathy
- Patients at known risk of thrombophilia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.