check_circleStudy Completed
Hemophilia A
Bayer Identifier:
13213
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
0 - N/ATrial summary
Enrollment Goal
26Trial Dates
August 2008 - September 2011Phase
N/ACould I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Netherlands | |
Completed | Many Locations, Slovenia | |
Completed | Many Locations, Germany | |
Completed | Many Locations, Italy | |
Completed | Many Locations, Spain | |
Completed | Many Locations, Austria | |
Completed | Many Locations, Greece |
Primary Outcome
- 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 requirementsdate_rangeTime Frame:During continuous infusionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- General tolerability and development of inhibitorsdate_rangeTime Frame:Within 14 days to 3 months after termination of continuous infusionenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
Biological/VaccineTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A