rFVIIa use in QLD. 2003 Since the “early days”, off license rFVIIa use in Queensland has tended to be at lower dose than the 90mcg/kg extrapolated from licensed indications.
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Since the “early days”, off license rFVIIa use in Queensland has tended to be at lower dose than the 90mcg/kg extrapolated from licensed indications.
Guideline for off license use of rFVIIa at Princess Alexandra Hospital developed by Director of Haematology in August 2003.
PAH is the lead site in Qld for clinical research, evidence based protocol driven care.
Other Qld Health sites use PAH Qld Health intranet site in the absence of local clinical guidelines
Haematologists were gatekeepers, so dose recommendation reinforced at authorisation stage & blood bank would query higher dose requests
Statewide guideline for off license rFVIIa use in Queensland Public Hospitals. Supercedes PAH guideline
Author Clinical Pharmacologist, consultation with clinical stakeholders
Gatekeeper role maintained at individual institutions (frequently with stronger interest in budget than haemostasis)
Evidence base for protocol .…
*Isbister et al 2008 IMJ (38):156-165
Medium dose chosen to encompass
median dose of ~90mcg/kg,
allowing for practice of rounding up to nearest 1.2 mg ampoule
No significant difference in Age, Gender, Hb, medications prior, platelets units prior, blood components after, case complexity, pH or temperature
Clinician defined Responder = bleeding stopped or decreased, Non-responder = bleeding unchanged or increased
Size of Dose? – not significant in either model
Mortality n=344, wald chi2 164.68, p <0.001
Response n=319, wald chi2 180.47, p <0.001
The Haemostasis Registry is funded by an unrestricted Educational Grant from Novo Nordisk Pharmaceuticals Pty Ltd
Baseline patient characteristics (including age, weight, gender, place of administration, pH, temperature, case complexity and medications, products administered and coagulation parameters prior to rFVIIa) were compared between groups using χ2 for categorical data, one-way ANOVA for normally distributed continuous data and the non-parametric Kruskal Wallis test for non-normally distributed continuous variables.
Response in bleeding to treatment (a clinical judgment made at the time of administration), mortality and TAEs were compared by dosage group using χ2. Multivariate analyses modelled the relationship between covariates (described in Table 4) and response to treatment and mortality using a backward step-wise approach.
A multilevel model was used as patients were clustered by hospital to account for institutional dosing practices.
Values p<0.05 were considered statistically significant. All analyses were conducted using Stata v. 9.2 (Stata Corp, Texas USA).