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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®) | 1 year |
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Inclusion Criteria:
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.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CH Le Mans |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®) |
Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg |
| 1 year |
| Le Mans |
| France |
| CHU de Nantes | Nantes | France |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |