Hemophilia
Conditions
Brief summary
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).
Interventions
OTHERno intervention
no intervention
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Regardless of age * No inhibitor (anti-FVIII alloantibodies) at the time of treatment. * No objections expressed to participate in the study after having been informed of its purposes and the data involved. * No other inherited hemorrhagic disorders than HA
Exclusion criteria
In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA | 1 year | Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors. | 1 year | Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®) |
| Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®) | 1 year | Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg |
Countries
France
Outcome results
None listed