Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type BIOLOGICAL

Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No