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

NCT04808349 | Completed

• 1 other identifier: RC21_0053
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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).

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (1)

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

  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)

  1 year

Secondary Outcomes (2)

• 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

• Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)

  1 year

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to respect the independence of the physicians, this study is conducted with patients for whom the decision to prescribe turoctocog alfa (NovoEight®) treatment is not related to the study. The prescription of turoctocog alfa (NovoEight®) will therefore have been carried out on the initiative of the physicians of the participating centers, in collaboration with the patients involved. This study therefore does not lead to any change in the usual medical care of the people entering the study, nor does it affect the physical or psychological integrity of the patients.

You may qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHU Angers

Angers, France

Location

CH Le Mans

Le Mans, France

Location

CHU de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: July 2, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

FR (3)