Clinical guidelines and off‐license recombinant activated factor VII: content, use, and association with patient outcomes

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.