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

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).

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA

Time frame: 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 outcomes

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.

Time frame: 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®)

Time frame: 1 year

Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: SERAPHINE

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Mar 22, 2021
Registry last updated: Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed