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

Bayer26 enrolled

Overview

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

Enrollment

Conditions

Hemophilia A

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)BIOLOGICAL

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Many Locations, Austria

Unnamed facility

Many Locations, Germany

Unnamed facility

Many Locations, Greece

Unnamed facility

Many Locations, Italy

Unnamed facility

Outcomes

Primary Outcomes

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 Outcomes

General tolerability and development of inhibitors

Time frame: Within 14 days to 3 months after termination of continuous infusion

Data from ClinicalTrials.gov

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