hemophilia A
Conditions
Interventions
DDAVP and FVIII concentrate combination treatment
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Non-severe hemophilia A patients (FVIII = 0.01 IU/mL) - In need of surgery or suffering from bleeding - Age minimally 12 and maximally 70 years at study inclusion date - Need for clotting factor concentrates - Treatment duration with FVIII-concentrates of at least 48 hours - Results of FVIII levels after a DDAVP test dose, or if test results are not available, willingness to undergo a DDAVP test - Male gender - (Parental) informed consent
Exclusion criteria
Exclusion criteria: - Patients with other congenital or acquired hemostatic abnormalities - Very low response to DDAVP after 1 hour – absolute increase in FVIII 0.5 BU) preoperatively, unless successfully treated with immunotolerance therapy - Contraindications for DDAVP, e.g. cardiovascular disease (see appendix IV) - Use of co-medication that has an interaction with DDAVP (see appendix IV) - Intolerance to previous DDAVP administrations - DDAVP not advisable due to type of surgery or bleeding according to the hematologist and/or surgeon - Start of FVIII-concentrate treatments >24 hours ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint will be the proportion of patients within FVIII target levels with DDAVP and FVIII concentrate combination treatment in the first 72 hours after surgery, without adding off-protocol FVIII concentrates | — |
Secondary
| Measure | Time frame |
|---|---|
| - A population based pharmacokinetic model - Number and nature of adverse events during combined treatment - Incidence & severity of bleeding - Incidence of thrombosis - Incidence and extent of tachyphylaxis - Economical evaluation - Experienced quality of care | — |
Contacts
Public ContactL.G.R. Romano
Erasmus MC - room Na-823
Outcome results
None listed