Bleeding
Conditions
Brief summary
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.
Interventions
DRUGFibryga
Fibryga
Sponsors
Octapharma
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of treatments given for an ongoing bleeding episodes | 6 months | Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| On-demand Treatment Success | 6 months | on-demand treatment of spontaneous or surgical bleeding episodes, success is defined as bleeding control (complete cessation of bleeding or \< 20% decrease in hemoglobin). |
| Surgical Prophylaxis Success | 6 months | 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). |
Countries
France
Outcome results
None listed