Hemophilia A, surgery, treatment, pharmacokinetic-guided, pharmacokinetics, costreduction
Conditions
Interventions
A multi-center open-label randomized controlled trial, with stratified randomization with regard to type of surgery (low or medium risk surgery) and dosing strategy (continuous, bolus) in patients age
Sponsors
Erasmus University Medical Center Rotterdam, Sophia Childrens Hospital
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Severe and moderate hemophilia A (FVIII plasma level >= 5%). - Elective and low or medium risk surgery as defined by surgical risk score (Koshy et al.) - >= 12 years of age at inclusion date for the randomized controlled trial; - Written informed consent, according to local law and regulations
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients with other congenital or acquired hemostatic abnormalities. - Withdrawal of (parental) informed consent. - Detectable FVIII inhibiting antibodies (>0.02 BU) at inclusion in study - General medical conditions which may interfere with participation in the study. - High-risk surgery - Acute surgical interventions Co-medication will be documented as this may influence the hemostatic system. Due to the intention to treat analyses that will be applied, patients who develop infectious complications after surgery or patients who develop inhibitors post-operatively within 4-10 weeks of surgery will be included in the statistical analyses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of infused FVIII concentrate (IU) per kilogram body weight during the peri-operative period per post-operative day (from 72 hours before surgery up to 14 days after surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peri-operative hemostasis as quantified by hemoglobin values pre- and postoperatively, blood loss and classification of blood loss as compared to expected blood loss in a hematologically healthy individual with that specific surgical procedure. 2. Achieved FVIII levels after recombinant FVIII infusion (IU ml-1). 3. Length of hospitalization (days). 4. Effect of baseline VWF antigen, VWF propeptide values and blood type on FVIII clearance. 5. Economic evaluation. | — |
Contacts
Public ContactIris van Moort
Erasmus University Medical Center - Sophia Children's Hospital
Outcome results
None listed