Hemophilia A
Conditions
Keywords
Continuous infusion, Surgery, Severe haemophilia A
Brief summary
The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.
Interventions
Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* In-patients with diagnosis of severe haemophilia A (FVIII \< 1%), heavily pretreated (\> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total consumption of FVIII (in IU/kg) during continuous infusion, FVIII:C achieved compared to expected levels, reasons and number of unplanned bolus infusion, amount of blood loss, transfusion requirements | During continuous infusion |
Secondary
| Measure | Time frame |
|---|---|
| General tolerability and development of inhibitors | Within 14 days to 3 months after termination of continuous infusion |
Countries
Austria, Germany, Greece, Italy, Netherlands, Slovenia, Spain
Outcome results
None listed