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netherlands journal of critical care in one hour of an initial CT scan, both of which occurred within 4 hours of symptom onset [31]. The end points of the study were the change in volume of the haematoma as assessed by repeat CT scans and clinical outcome. Patients receiving rFVIIa had significantly less increase in the haematoma volume. The placebo group had a 29% increase in the haematoma at 24 hours compared to an increase of 16%, 14% and 11% for the 40, 80 and 160mcg/kg groups respectively. Overall, pooled data for all doses resulted in a 52% relative reduction in haematoma volume compared with placebo. Patients receiving rFVIIa had significantly less disability at three months compared to patients receiving placebo, and there was a 38% relative reduction in mortality. Finally, there was a trend to suggest that earlier administration and larger doses produced improved end points. However, there was an increase in thromboembolic events including seven patients with myocardial infarction and nine with cerebral infarction in the treatment groups. Overall there were two serious thromboembolic events in the placebo group and 21 in the treatment group. This difference was significant although the number of fatal or disabling thromboembolic events was not significantly increased. On the basis of this study, rFVIIa will probably become a useful therapeutic agent although the ideal dose and patient population at high risk of ischaemic complications is yet to be identified. Thromboembolic Complications A recent article has reviewed the number of thromboembolic complications (TECs) that have been voluntarily reported to the American federal Drug Administration following rFVIIa use over a five year period [82]. During this time, there were 168 reports that were deemed to be true TECs secondary to rFVIIa, 28 of which were in patients with haemophilia. This compares with 4 520 patients who received rFVIIa in the year 2004 alone. Of the 168 TEC’s, there were 39 cerebro-vascular events, 34 acute myocardial infarctions, 32 pulmonary emboli and 42 deep vein thromboses. There were also splenic, retinal vein, femoral and renal artery thromboses. Eighteen percent occurred within two hours of the last dose of rFVIIa (compatible with the elimination half-life of 2.3 hours for rFVIIa) and 52% of TECs occurred within 24 hours. There were 36 deaths that were thought to be due to the TEC. However only 102 cases of the 168 included a causality assessment of which 81 were deemed to be probably or possibly secondary to the rFVIIa. Finally there were also 193 reports pertaining to a lack of benefit following administration. Conclusion There is a significant body of evidence to suggest that rFVIIa is safe with only minimal thrombo-embolic complications. There are also many ‘last-ditch’ case reports illustrating a beneficial effect of rFVIIa in a number of life-threatening surgical and non-surgical clinical settings. And if this drug is present within the hospital, it becomes emotionally and ethically difficult not to use it as a rescue therapy in lifethreatening haemorrhage. However, there is undoubtedly a degree of positive bias reporting in the literature when describing rFVIIa in this clinical scenario. Also, in an era of increasing concern regarding the rapidly expanding public health expenditure, rFVIIa remains a very costly therapy whose non-evidenced based, off-licence use may impact on the provision of other therapies. In those areas where clinical efficacy has been relatively established such as in patients with haemophilia or patients with a recent intracerebral haemorrhage, we would recommend the use of rFVIIa as described by the trials. In the majority of clinical settings though, there is a lack of prospective randomised-controlled trials of rFVIIa. Thus far, the few that have been performed have shown minimal mortality benefit. Without a body of well performed, randomisedcontrolled trials, we would recommend that the use of this agent is reserved for last ditch salvage situations where all conventional treatments have at least been initiated, and shown to have failed in patients with life-threatening surgical bleeding. References 1. Hedner U, Kisiel W. Use of human factor VIIa in the treatment of two haemophilia A patients with high titer inhibitors. J Clin Invest 1983;71:1836-1841 2. Abshire T, Kenet G. Recombinant factor VIIa : review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors. J Thromb Haemost 2004;2:899-909 3. Kenet G, Walden R, Eldad A, Martinowitz U. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999;354:1879 4. 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The action of high-dose factor VIIa (FVIIa) in a cell-based model of haemostasis. Semin Hematol 2001;38:6-9 11. Pusateri AE, Park MS. Mechanistic implications for the use and monitoring of recombinant activated factor VII in trauma. Crit Care 2005;9(Suppl 5):S15-S24 12. Lisman T, De Groot PG. Mechanism of action of recombinant factor VIIa. J Thromb Haemost 2003;1:1138-1139 13. Van’t Veer C, Mann KG. The regulation of the factor VIIdependent coagulation pathway : rationale for the effectiveness of recombinant factor Viia in refractory bleeding disorders. Semin Thromb Hemost 2000;26:367-372 14. Monroe DM, Hoffman M, Oliver JA, Roberts HR. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 1997;99:542-547 15. Lisman T, Adelmeijer J, Cauwenberghs S, Van Pampus EC, Heemskerk JW, De Groot PG. Recombinant factor VIIa enhances platelet adhesion and activation under flow conditions at normal and reduced platelet count. J Thromb Haemost 2005;3:742-751 16. 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