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).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effect of the administration of fibrinogen and the transfusion of a platelet concentrate on the visco-elastometric parameter 'maximum clot elasticity' (MCE) deduced from the MCF "maximum clot firmness" of the EXTEM curve (ROTEM - initiation of coagulation with tissue factor) between the 1st and 3rd laboratory investigation (1st before administration of fibrinogen, and 3rd after administration of fibrinogen and platelets).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Effect of the administration of fibrinogen and the transfusion of a platelet concentrate on the visco-elastometric parameter 'maximum clot elasticity' (MCE) deduced from the MCF "maximum clot firmness" of the EXTEM curve (ROTEM - initiation of coagulation with tissue factor) between the 1st and 3rd laboratory investigation (1st before administration of fibrinogen, and 3rd after administration of fibrinogen and platelets).
Effect of the administration of fibrinogen and the transfusion of a platelet concentrate on the visco-elastometric parameter 'maximum clot elasticity' (MCE) deduced from the MCF "maximum clot firmness" of the EXTEM curve (ROTEM - initiation of coagulation with tissue factor) between the 1st and 3rd laboratory investigation (1st before administration of fibrinogen, and 3rd after administration of fibrinogen and platelets).
次要结局
- Comparison of the ROTEM viscoelastometric parameters before and after treatment, under EXTEM and FIBTEM conditions (determination of the contribution of fibrinogen) and with all the other ROTEM parameters between the 1st, 2nd and 3rd laboratory investigation.
- Comparison of all parameters in ROTEM viscoelastometry under EXTEM and FIBTEM conditions before and after platelet transfusion as a function of CCI and the cause in the refractory state.
- Comparison of parameters in ROTEM viscoelastometry before and after platelet transfusion as a function of the characteristics of the platelet concentrates.
- Comparison of the ROTEM viscoelastometry parameters before and after fibrinogen as a function of the dose received relative to the patient's weight and the plasma concentration of fibrinogen
- Incidence of hemorrhagic events and thrombotic events
- Collection of hemorrhagic and thrombotic risk factors.
- Time from diagnosis of bleeding to administration of treatment; delay between the first ROTEM results and the administration of treatments; and ROTEM results before and after procedures.
- Time to get the first ROTEM result and the result of conventional coagulation tests and complete blood count after blood collection.
- Collection of adverse events and serious adverse events.
研究者
project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne