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BIOSTATE produced excellent/good hemostatic efficiency in 90% of surgical bleeding events
Howman R. Haemophilia. 2011;DOI:10.1111/j.1365-2516.2010.02445.x.
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Results from a retrospective review of 43 children with von Willebrand disorder showed that BIOSTATE produced high rates of hemostatic efficiency.
BIOSTATE is a high purity, plasma-derived factor VIII/von Willebrand factor concentrate licensed in Australia and New Zealand for use when DDAVP is ineffective.
Researchers performed a retrospective chart review at eight pediatric centers in Australia and New Zealand. Patients were grouped according to whether they received BIOSTATE for a surgical event, non-surgical bleed or for long-term prophylaxis. Surgical events were further categorized as either major, such as appendectomy, or minor, such as skin procedures or dental extractions.
Ten patients underwent 10 major surgeries and 21 patients underwent 32 minor surgical events. Mean daily FVIII:C dose of BIOSTATE for all surgical events was 47 IU FVIII:C kg-1 and median treatment duration was 3 days. Hemostatic efficacy for all surgical events was rated excellent/good in approximately 90% of events.
Similarly, hemostatic efficacy was excellent/good in 90% of major surgeries and 91% of minor surgeries.
Seven major and 16 minor surgical events were assessed for blood loss. Researchers determined that bleeding was less than or equal to what would be expected in a patient without a bleeding disorder.
Hemostatic efficacy for all non-surgical events was rated excellent/good in 94% of events. Hemostatic efficacy improved to 98% for patients with von Willebrand disorder type 3.
There was a single case of nausea reported that may have been associated with BIOSTATE. There was no incidence of viral seroconversions reported.
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