Hemophilia A, Hemophilia B
Conditions
Keywords
surgery, Haemophilia A, Haemophilia B, Elocta®, Alprolix®
Brief summary
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy. In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX. Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.
Interventions
DRUGDescribe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures
All surgical data will be collected: surgery, biology, administration of Elocta®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding
DRUGDescribe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
All surgical data will be collected: surgery, biology, administration of Alprolix®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding…
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patient with Haemophilia A or B * surgery performed with Elocta® or Alprolix® * Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
Exclusion criteria
* Any blood coagulation disorder other than Haemophilia A or B * Patient with factor VIII or IX inhibitor * Severe liver disease (serum ALAT/ASAT levels\> 5 x ULN) * Severe renal disease (serum creatinine \> 2x ULN) * Known hypersensitivity to the substances or its excipients * patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor. | 15 days post-surgery | changes in hemostatic efficacy between surgery and 15 days post-surgery |
Countries
France
Contacts
Primary ContactAnne LIEHNART, MD
Backup ContactEmilie PROME COMBEL, RCA
Outcome results
None listed