abnormal clot formation bleeding disorder
Conditions
Interventions
When an indication for elective low- or medium risk surgery is established, in
all included patients, a PK-profile based on Bayesian analysis will be
constructed pre-operatively prior to randomizati
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Severe and moderate hemophilia A (FVIII plasma level *5%) - Elective and low or medium risk surgery as defined by surgical risk score - * 12 years of age at inclusion date for the randomized controlled trial -
Exclusion criteria
Exclusion criteria: - Patients with other congenital or acquired hemostatic abnormalities. - Withdrawal of (parental) informed consent. - Detectable FVIII inhibiting antibodies (>0,2 BU) at inclusion in study. - General medical conditions which may interfere with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of infused FVIII concentrate (IU) per kilogram body weight during peri-operative period per post-operative day (0-14 days after surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peri-operative hemostasis as quantified by hemoglobin values pre- and postoperative, blood loss and classification of expected blood loss during surgical procedure as documented by standardized form. 2. Achieved FVIII levels after FVIII infusion (IU ml-1) 3. Length of hospitalization (days). 4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII clearance. 5. Economic evaluation. | — |
Countries
Netherlands
Outcome results
None listed