Brief Title
Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
Official Title
Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
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).
Study Type
Observational
Primary Outcome
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
Secondary Outcome
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.
Condition
Hemophilia
Intervention
no intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
100
Start Date
July 2, 2021
Completion Date
April 1, 2022
Primary Completion Date
April 1, 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04808349
Organization ID
RC21_0053
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
, ,
Verification Date
August 2021