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A consensus statement on clinical trials of bypassing agent prophylaxis in inhibitor patients
Authors:J. TEITEL  E. BERNTORP  G. DOLAN  K. FISCHER  A. GRINGERI  C. KESSLER  T. LAMBERT  C. LEISSINGER  L. NEMES  M. SHIMA
Affiliation:1. St Michael’s Hospital Department of Medicine and the University of Toronto, Toronto, ON, Canada;2. Lund University, Malm? Centre for Thrombosis and Haemostasis, Malm?, Sweden;3. Nottingham University Hospitals, Queens Medical Center, Nottingham, UK;4. van Creveldkliniek, Utrecht, The Netherlands;5. A. Bianchi Bonomi Haemophilia and Thrombosis Center, University of Milan, Milan, Italy;6. Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA;7. H?pital de Bicêtre AP‐HP, Paris, France;8. Louisiana Center for Bleeding and Clotting, Tulane University Medical Center, New Orleans, LA, USA;9. State Health Center, Budapest, Hungary;10. Department of Pediatrics, Nara Medical University, Kashihara, Japan
Abstract:Summary. The haemophilia literature increasingly contains reports describing the use of bypassing agent prophylaxis (BAP) in patients with severe haemophilia A and inhibitors. However, it is difficult to interpret and compare the results and draw conclusions about treatment efficacy because of small patient numbers and a lack of standardization among BAP studies. This article presents consensus recommendations for standardizing future BAP clinical trials developed by an international panel of haemophilia opinion leaders.
Keywords:activated prothrombin complex concentrate  activated recombinant factor VII  bypassing therapy  haemophilia  inhibitors  prophylaxis
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