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Regional variation of the off-licence use of rFVIIa for patients with uncontrolled haemorrhage in England


In 1999 the first publication appeared of the use of recombinant factor VIIa (rFVIIa) for uncontrolled haemorrhage [1]. Since then there has been widespread international use of rFVIIa in this setting. Consensus guidelines have been published [2], but there is much variation in its administration [3].


Review of the blood bank databases of all six acute hospitals in the southwest of England between January 2000 and February 2009 was undertaken to reveal all prescriptions of rFVIIa. Case notes were analysed and the administration of all blood products for 24 hours either side of rFVIIa administration was extracted from the blood bank databases.


Eighty-two patients were identified who had received off-licence rFVIIa. Of these, full data were available on 67 patients. There was unequal use between hospitals; Plymouth had 33% of use compared with Taunton, with only 4%. A total 65.7% of patients were male and the mean age was 56.6 years. The mean APACHE II score was 18.4 (± 7.4) and 40.3% patients died in ≤96 hours. The mean dosage administered was 80.9 μg/kg (± 21.3). The number of annual prescriptions shows a bimodal pattern with peaks in 2005 and 2008. The distribution of usage was predominantly with general and vascular surgical patients (39%), but trauma (14.9%), obstetrics (13.4%) and cardiac surgery (13.4%) were the next most frequent specialties. rFVIIa was given after a mean of 17.6 (± 11.2) units of packed red cells, 8.8 (± 5.9) units of fresh frozen plasma and 2.3 (± 1.9) pooled platelets. Following rFVIIa transfusion of all blood products was markedly less, and only three patients received a repeat dose of rFVIIa. The prothrombin time decreased from a mean of 18.9 seconds to 13.9 seconds following rFVIIa. Thirty-six per cent of patients had <50 platelets at administration and 40% were acidotic with pH <7.2. Sixty-eight per cent patients had a haematocrit <0.25 and 30% of patients were hypothermic.


Off-label prescribing of rFVIIa varies widely across the southwest region. Its use as an adjunctive therapy for uncontrolled haemorrhage has often been unsuccessful. Our analysis of prescribing rFVIIa in this setting reflects the practice of the larger Australian series in terms of indications and dosage; however, the mortality at 28 days of 32% is lower than in our series [3]. There is still heterogeneity in prescribing rFVIIa and its use does not conform to European guidelines [2].


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Correspondence to MH Spivey.

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Spivey, M., Eve, R. & Duffy, M. Regional variation of the off-licence use of rFVIIa for patients with uncontrolled haemorrhage in England. Crit Care 14, P371 (2010).

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  • Prothrombin
  • Factor VIIa
  • Blood Product
  • Adjunctive Therapy
  • Fresh Freeze Plasma