se of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion

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) - FORMAT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000990-10-FR

Enrollment

Registered

2021-03-09

Start date

2021-07-22

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: CLOTTAFACT Pharmaceutical Form: Powder and solution for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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; - Body weight between 38 and 78 kg; - Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI); - Patient affiliated to a social security scheme Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: - Patient who expressed his opposition to participating in the study; - 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 (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9); - Patient with non-malignant hematological involvement; - Patient with a high plasma fibrinogen concentration (> 5g / L); - Patient allergic to fibrinogen; - Patient with disseminated intravascular coagulopathy; - Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: - Evaluate the effect of each treatment administered on the ROTEM viscoelastometry results and the persistence of this effect at 24 hours - Evaluate the hemostatic response to platelet transfusion according to the Corrected Count Increment and the cause in the refractory state - Evaluate the visco-elastometric response according to the characteristics of the transfused platelet concentrates - Evaluate the hemostatic response to fibrinogen as a function of the dose received relative to the patient's weight and the plasma concentration of fibrinogen obtained - Evaluate the incidence of hemorrhagic and thrombotic events - Evaluate the impact of hemorrhagic and thrombotic risk factors - Evaluate the time taken to implement anti-haemorrhagic treatment - Compare the availability of the results of the usual coagulation tests and of the blood count with that of the results of the visco-elastometric tests - Evaluate the incidence of adverse events;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 1 day	—

Measure

Time frame

Main Objective: 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;Secondary Objective: - Evaluate the effect of each treatment administered on the ROTEM viscoelastometry results and the persistence of this effect at 24 hours - Evaluate the hemostatic response to platelet transfusion according to the Corrected Count Increment and the cause in the refractory state - Evaluate the visco-elastometric response according to the characteristics of the transfused platelet concentrates - Evaluate the hemostatic response to fibrinogen as a function of the dose received relative to the patient's weight and the plasma concentration of fibrinogen obtained - Evaluate the incidence of hemorrhagic and thrombotic events - Evaluate the impact of hemorrhagic and thrombotic risk factors - Evaluate the time taken to implement anti-haemorrhagic treatment - Compare the availability of the results of the usual coagulation tests and of the blood count with that of the results of the visco-elastometric tests - Evaluate the incidence of adverse events;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 1 day

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Secondary

Measure	Time frame
Secondary end point(s): - 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, namely: CT = clotting time; CFT = time of clot formation; angle alpha (a); MCF = maximum firmness of the clot; amplitude 5 min after CT (A5); amplitude 10 min after CT (A10); amplitude 20 min after CT (A20); amplitude 30 min after CT (A30); and maximal lysis (ML); and by the “maximal clot firmness” in FIBTEM - 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 (measured by the usual laboratory test). - 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.;Timepoint(s) of evaluation of this end point: 2 months	—

Measure

Time frame

Secondary end point(s): - 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, namely: CT = clotting time; CFT = time of clot formation; angle alpha (a); MCF = maximum firmness of the clot; amplitude 5 min after CT (A5); amplitude 10 min after CT (A10); amplitude 20 min after CT (A20); amplitude 30 min after CT (A30); and maximal lysis (ML); and by the “maximal clot firmness” in FIBTEM - 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 (measured by the usual laboratory test). - 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.;Timepoint(s) of evaluation of this end point: 2 months

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Countries

France

Contacts

Public ContactElisabeth Daguenet

Institut de Cancérologie Lucien Neuwirth

elisabeth.daguenet@icloire.fr+330477917089+33

Outcome results