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Blood, 15 January 2002, Vol. 99, No. 2, pp. 450-456
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Treatment of von Willebrand disease with a high-purity factor
VIII/von Willebrand factor concentrate: a prospective, multicenter
study
Pier M. Mannucci,
Juan Chediak,
Wahid Hanna,
John Byrnes,
Marlies Ledford,
Bruce M. Ewenstein,
Anastassios D. Retzios,
Barbara A. Kapelan,
Richard S. Schwartz,
Craig Kessler, and
the Alphanate Study Group
From the Angelo Bianchi Bonomi Hemophilia and
Thrombosis Center, IRCCS Maggiore Hospital and University of Milan,
Italy; Illinois Masonic Medical Center, Chicago; University of
Tennessee, Knoxville; University of Miami, FL; Brigham and Women's
Hospital, Boston, MA; Alpha Therapeutic Corporation, Los Angeles, CA;
George Washington University Medical Center, Washington, DC; and the
Alphanate Study Group.
Among patients with von Willebrand disease (VWD) who are
unresponsive to desmopressin therapy, replacement with plasma-derived concentrates is the treatment of choice. Because prospective studies are lacking, such treatment has been largely empirical. A multicenter, prospective study has been conducted in 81 patients with VWD (15 patients with type 1, 34 with type 2, and 32 with type 3 disease) to
investigate the efficacy of a high-purity factor VIII/von Willebrand factor (FVIII/VWF) concentrate for treatment of bleeding and surgical prophylaxis. Two preparations of the concentrate one virally
inactivated with solvent detergent, the other with an additional
heat-treatment stepwere evaluated. Pharmacokinetic parameters were
similar for both preparations. Using pre-established dosages based on
the results of pharmacokinetic studies, 53 patients were administered either preparation for the treatment of 87 bleeding episodes, and 39 patients were treated prophylactically for 71 surgical or invasive
procedures. Sixty-five (74.7%) and 10 (11.5%) of the bleeding
episodes were controlled with 1 or 2 infusions, respectively. Patients
with severe type 3 VWD typically required more infusions and higher
doses, at shorter time intervals, than did patients with generally
milder types 1 and 2. Among patients undergoing surgical procedures,
blood loss was lower than that predicted prospectively, and losses
exceeding the predicted value did not correlate with the postinfusion
skin bleeding time. In conclusion, the concentrate effectively stopped
active bleeding and provided adequate hemostasis for surgical or
invasive procedures, even in the absence of bleeding time correction.
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