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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibryga |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibryga | Drug | Fibryga |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Surgical Prophylaxis Success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having received Fibryga® ("on-demand" or for regular prophylaxis) in the centres participating in the study during the recollection period (limited to 7 patients by centre and by period). A total of 4 recollection periods is planned by centre.
Data from all consecutive patients having received Fibryga® whatever the indication (congenital or acquired fibrinogen deficiency; "on-demand" or regular prophylaxis) will be collected. The data collection will be limited to 7 patients by centre and by period, meaning that only data from the 7 first patients treated during the recollection period willbe collected.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux Study Site | Bordeaux | 33404 | France | |||
| Le Plessis Robinsin Study Site |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
| 6 months |
| Le Plessis-Robinson |
| 92350 |
| France |
| Marseille Study Site | Marseille | 13285 | France |
| Nantes Study Site | Nantes | 44093 | France |
| Valence Study Site | Valence | 26953 | France |