Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
Completed
- Conditions
- Hemophilia A
- Interventions
- Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Registration Number
- NCT00922597
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Recombinant Factor VIII (Kogenate FS, BAY14-2222) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method General tolerability and development of inhibitors Within 14 days to 3 months after termination of continuous infusion