Trial Condition(s):
Hemophilia A
Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery (NO PEACKS)
Bayer Identifier:
13213
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery - NO PEACKS
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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 requirementsTimeframe: During continuous infusion
Secondary Outcome
- General tolerability and development of inhibitorsTimeframe: Within 14 days to 3 months after termination of continuous infusion
Additional Information
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