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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).

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516494-73-00
Acronym
2021-0201
Enrollment
10
Registered
2024-08-29
Start date
2022-02-10
Completion date
2025-12-17
Last updated
2024-10-24

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

Conditions

Hematological malignancy

Brief summary

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).

Detailed description

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.

Interventions

DRUGCLOTTAFACT 1
DRUG5 G/100 ML

Sponsors

Centre Hospitalier Universitaire De Saint Etienne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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 ROT

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026