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• W2083229571 abstract "There is a growing body of evidence to support the use of recombinant factor r(F)VIIa in cases of excessive bleeding outside its approved use in hemophilia with inhibitors [1, 2]. Concerns regarding its use in patients at higher risk of surgical site related thrombosis, such as during cardiac artery and vascular surgery have been raised [3]. In an effort to monitor efficacy and potential adverse events NovoNordisk have been collecting data through an international database (http://www.haemostasis.com). At the recent Haematology Society of Australia and New Zealand (HSANZ) meeting database cases were reviewed (cases up until September 2003) [4]. There were 943 entries from the ‘world’ vs. only 23 cases from Australia and New Zealand [including seven cases from Prince of Wales Hospital (POWH)]. The comparison was, however, strikingly different. The HSANZ cases showed a thrombosis rate of 30% compared with 1.8% for the world (Table 1). The breakdown of thrombosis seen in the HSANZ cases is as follows: two myocardial infarcts, one deep vein thombosis (DVT), one pulmonary embolism (PE), one arterial, one cerebral and one renovascular thrombosis. Why is this the case? Is this related to a reporting bias given the paucity of cases reported compared with overall usage, or are we using Novoseven in a different manner (timing, dosing, frequency) to our international colleagues? In an effort to address the issue of possible reporting bias we analyzed our first 10 consecutive ‘off license’ uses of Novoseven at POWH (compared with random anecdotal reporting of the HSANZ cases). One renal transplant case was associated with late renal vascular thrombosis in association with abdominal sepsis, which was felt ‘unlikely’ to be related to the recombinant factor VIIa dose 3 days earlier. Otherwise no thrombotic events were observed. In addition, six patients were at relatively high vascular thrombotic risk; four had coronary artery bypass grafts and two had renal transplants. Thus, in a systematic review of one of the HSANZ sites there did not appear to be a higher rate of thrombosis, which may imply an element of reporting bias to the database. The rate of massive transfusion (defined in the database as greater than five units of packed cell transfusion) before Novoseven was administered, was 83% for the HSANZ cases compared with only 40% from the world database. The median units of blood transfused prior to use of Novoseven was significantly higher (Fig. 1) between HSANZ cases (21 units) and the world database (12 units) (P = 0.03). The Australian practice thus far has been to use Novoseven when conventional measures (blood products and further surgery) have failed to achieve haemostasis, rather than as an adjunct to these therapies. This presumably could lead to a poorer response rate and possibly a higher thrombosis rate given the overall poorer health of the patient. Having said the former, the overall response rate (> 90% in each group) and average units transfused following Novoseven (HSANZ 5.3 U; World 4.9 U) were not different. Transfusion rate prior to use of Novoseven. Only one of the HSANZ cases had thrombosis at the site of surgery (renal transplant), the remainder having thrombosis at other sites (e.g. DVT) which may be considered an indirect effect of improved haemostasis or as mentioned an already frequent complication in a critically ill patient. Indeed in the cardiac artery surgery patients, who may be at highest risk of site related thrombosis, none were seen. Anecdotally Australia has reported a higher thrombosis rate than recorded in the world database. However comprehensive reporting from an individual center would suggest that the thrombosis rate is not increased. Australia uses Novoseven significantly later in massive hemorrhage than the rest of the world, which may conversely be contributory to an increase in thrombosis due to a poorer patient health status. Novoseven remains an effective and safe treatment of intractable bleeding. We would like to thank the Australian hematologists whom contributed to the database." @default.
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• W2083229571 date "2004-10-01" @default.
• W2083229571 modified "2023-09-30" @default.
• W2083229571 title "Is there a high thrombosis rate associated with recombinant factor VIIa use in intractable hemorrhage in Australia?" @default.
• W2083229571 cites W2084006599 @default.
• W2083229571 doi "https://doi.org/10.1111/j.1538-7836.2004.00846.x" @default.
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