Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery (SERAPHINE)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Hemophilia

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04808349

RC21_0053

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.