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Analysis of the off-licence use of recombinant activated factor VII for patients with uncontrolled haemorrhage in a UK tertiary referral hospital


Recombinant activated factor VII (rFVIIa) is increasingly used for the treatment of acquired coagulopathies associated with uncontrolled haemorrhage. Consensus guidelines [1] have been published for the administration of rFVIIa in this setting. We examined the off-licence use of rFVIIa in our 1,071-bed tertiary referral hospital.


Hospital blood-bank data were examined from the first off-licence use of rFVIIa in November 2002 until August 2008. Case notes were reviewed on these patients to gain demographics, indications and dosage of rFVIIa. Pathology data were cross-referenced to gain results before and after administration of rFVIIa.


Twenty-two patients were identified over the 6-year period who received off-licence rFVIIa. The majority of uses were in cardiac surgery (nine patients), followed by general/vascular surgery (five patients), and trauma (four patients). Of these patients, 41% (nine patients) did not survive >24 hours. Mean dosage was 7.8 mg (89.4 μg/kg) and was given after mean transfusions of 24.8 units of packed red cells, 13 units of fresh frozen plasma, 3.5 units of pooled platelets and 2 units of cryoprecipitate, in the preceding 24 hours. At this time, blood tests reveal a mean of 91 platelets (SD = 54.9), but nearly one-quarter of patients received the drug with a platelet count <50; prothrombin time 17.9 seconds, activated partial thromboplastin time 58.7 seconds, and pH 7.18. Mean temperature prior to rFVIIa administration was 34.7°C. Full APACHE II data were available for 64% of the patients with a mean of 18.3 (SD = 6.5), and for the trauma patients a mean revised trauma score of 5.9. Following the administration of rFVIIa, the mean prothrombin time reduced to 13.4 seconds at 1 hour. Sixty-eight per cent of patients (15) received blood product transfusions in the immediate 24 hours after having rFVIIa with a mean of 2 units packed red cells, 3.2 units fresh frozen plasma, 1.5 units pooled platelets and 1.1 units cryoprecipitate.


In our establishment, off-licence use of rFVIIa has often been unsuccessful and may have been used as salvage therapy. There is heterogeneity in prescribing rFVIIa and its use does not conform to European guidelines [1]. Controversy continues about the merits of using off-licence rFVIIa at all [2].


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  2. Stanworth S, et al.: Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev 2007, 2: CD005011.

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Spivey, M., Eve, H. & Duffy, M. Analysis of the off-licence use of recombinant activated factor VII for patients with uncontrolled haemorrhage in a UK tertiary referral hospital. Crit Care 13 (Suppl 1), P432 (2009).

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  • Prothrombin Time
  • Partial Thromboplastin Time
  • Salvage Therapy
  • Fresh Freeze Plasma
  • Consensus Guideline