Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

Octapharma200 enrolled

Overview

To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Bleeding

Interventions

FibrygaDRUG

Fibryga

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with fibrinogen deficiency (congenital or acquired) * Having received an treatment with Fibryga® during the recollection period * Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse. Exclusion Criteria: * N/A

Locations (5)

Bordeaux Study Site

Bordeaux, France

Le Plessis Robinsin Study Site

Le Plessis-Robinson, France

Marseille Study Site

Marseille, France

Nantes Study Site

Nantes, France

Valence Study Site

Outcomes

Primary Outcomes

proportion of treatments given for an ongoing bleeding episodes

Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis)

Time frame: 6 months

Secondary Outcomes

On-demand Treatment Success

on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or \< 20% decrease in hemoglobin).

Time frame: 6 months

Surgical Prophylaxis Success

Surgical prophylaxis success is defined as no bleeding or oozing and control of bleeding with fibrinogen concentrate (as anticipated or requiring increased dosing or additional infusions not originally anticipated).

Time frame: 6 months

Data from ClinicalTrials.gov

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