Hemophilia A ORPHA:169802 D66
Conditions
Interventions
Group 1: Patients with hemophilia A who are treated with efanesoctocog alfa (Altuvoct®) during surgical procedures
Sponsors
Gesellschaft für Thrombose- und Hämostaseforschung (GTH) , Ständige Kommission Hämophilie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patients with haemophilia A and surgical intervention - Treatment with efanesoctocog alfa (Altuvoct®) perioperatively - Patients undergoing therapy with emicizumab who receive efanesoctocog alfa (Altuvoct®) in addition to the surgical procedure
Exclusion criteria
Exclusion criteria: - Known blood coagulation disorders other than hemophilia A - Treatment with other factor VIII preparations perioperatively - Known active factor VIII inhibitor (= 0.6 Bethesda units (BU)/ml) - History of hypersensitivity or allergy to factor VIII preparations - Failure to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Hemostatic effectiveness as assessed by the surgeon/attending physician - Estimated blood loss during surgery in ml - Number and severity of bleeding during and up to day 14 after surgery (major procedures) or day 7 after surgery (minor procedures) | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of surgery - Consumption of Altuvoct in IU until day 14 after major surgery and day 7 after minor surgery - Number of intravenous injections up to day 14 after major surgery and day 7 after minor surgery - Hemostatically effective medication in the perioperative phase o Medication for thrombosis prophylaxis such as low-molecular-weight heparin o Tranexamic acid - Safety endpoints: o Intolerance reactions o Allergies o Thrombotic events o Inhibitor development | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactRobert Klamroth
Vivantes Klinikum im Friedrichshain , Klinik für Angiologie/ Hämostaseologie
Outcome results
None listed