Document Detail

Clinical guidelines and off-license recombinant activated factor VII: content, use, and association with patient outcomes.
MedLine Citation:
PMID:  19804534     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Recombinant activated factor VII (rFVIIa) is increasingly being used off-license for treating critical bleeding. Guidelines may therefore be useful for improving processes and outcomes. Little is known regarding guidelines for off-license rFVIIa or their association with patient outcomes. OBJECTIVES: To investigate the availability of hospital guidelines for off-license rFVIIa use and the association between these guidelines and mortality. METHODS: Data were extracted from the Haemostasis Registry, which collects all cases of off-license rFVIIa use in participating institutions in Australia and New Zealand. Contributing hospitals were requested to supply a copy of the institutional guideline relating to off-license rFVIIa administration. The characteristics of patients treated in accordance with all elements of the guidelines were compared with those of patients for who one or more guideline elements had been violated. The relationship between guideline-directed treatment and 28-day mortality was investigated using stepwise logistic regression. RESULTS: Two thousand five hundred and fifty-one patients in 75 hospitals were available for analysis. Of these hospitals, 58 provided a guideline for analysis. Patients complying with all guideline elements (n = 530) did not differ from patients receiving care that violated guidelines (n = 1035) regarding age, size of dose, or gender. Guideline-directed treatment was not found to have an association with 28-day mortality following logistic regression. CONCLUSIONS: Few patients are treated in accordance with the criteria of rFVIIa guidelines, despite their availability in the majority of hospitals. Moreover, 28-day mortality does not appear to be associated with the use of guidelines in this patient group. Refinement of guidelines relating to the off-license use of rFVIIa is therefore required.
C D Willis; P A Cameron; L E Phillips
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-10-05
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  7     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-18     Completed Date:  2010-03-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  England    
Other Details:
Languages:  eng     Pagination:  2016-22     Citation Subset:  IM    
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
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MeSH Terms
Factor VIIa / therapeutic use*
Guideline Adherence / statistics & numerical data*
Hemophilia A / drug therapy,  mortality*
Hospitals / standards*
New Zealand
Practice Guidelines as Topic / standards*
Recombinant Proteins / therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Recombinant Proteins; 0/recombinant FVIIa; EC VIIa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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