Brief Title
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
Official Title
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery - NO PEACKS
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.
Study Type
Observational
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 requirements
Secondary Outcome
General tolerability and development of inhibitors
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
26
Start Date
August 2008
Completion Date
September 2011
Eligibility Criteria
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.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00922597
Organization ID
13213
Secondary IDs
KG0701
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
April 2015