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Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery (NO PEACKS)

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ClinicalTrials.gov Identifier: NCT00922597
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hemophilia A Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Design

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery - NO PEACKS
Study Start Date : August 2008
Study Completion Date : September 2011


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: During continuous infusion ]

Secondary Outcome Measures :
  1. General tolerability and development of inhibitors [ Time Frame: Within 14 days to 3 months after termination of continuous infusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients with a diagnosis of severe haemophilia A. Physicians should consult the full prescribing information for KOGENATE Bayer before enrolling patients and familiarize themselves with the safety information in the product information.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922597


Locations
Austria
Many Locations, Austria
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Italy
Many Locations, Italy
Netherlands
Many Locations, Netherlands
Slovenia
Many Locations, Slovenia
Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00922597     History of Changes
Other Study ID Numbers: 13213
KG0701 ( Other Identifier: Company internal )
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

Keywords provided by Bayer:
Continuous infusion
Surgery
Severe haemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants