Observing surgical practices in patients with Hemophilia A or B treated with extended half-life factors
Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Hospices Civils de Lyon · NCT06158334
This study looks at how well extended half-life treatments for Hemophilia A or B work during surgery to see if they keep patients safe and reduce the need for frequent infusions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT06158334 on ClinicalTrials.gov |
What this trial studies
This study observes the surgical management of patients with Hemophilia A or B who are treated with extended half-life recombinant factor VIII (Elocta®) or factor IX (Alprolix®). It aims to evaluate the haemostatic efficacy of these treatments during surgical procedures, focusing on their ability to maintain stable factor levels while minimizing infusion frequency. The study will include patients undergoing surgery while receiving these therapies, providing insights into their effectiveness in real-world surgical settings.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Hemophilia A or B who are scheduled for surgery and are being treated with Elocta® or Alprolix®.
Not a fit: Patients with other blood coagulation disorders, inhibitors to factor VIII or IX, or severe liver or renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and safety for patients with Hemophilia A and B by optimizing peri-operative management.
How similar studies have performed: Previous studies have demonstrated good haemostatic efficacy of extended half-life factors in surgical settings, suggesting a positive outlook for this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bron
- Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon — Bron, France (RECRUITING)
Study contacts
- Study coordinator: Anne LIEHNART, MD
- Email: anne.lienhart@chu-lyon.fr
- Phone: +33 4 72 11 88 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemophilia A, Hemophilia B, surgery, Haemophilia A, Haemophilia B, Elocta®, Alprolix®