The choice of lab assay for treatment monitoring is another open

The choice of lab assay for treatment monitoring is another open issue [22]. The most widely used method is the FVII:C assay; probably the most appropriate tool for monitoring the treatment with plasma-derived FVII concentrates

as pdFVII infusions in FVII Fulvestrant deficient patients are a simple substitution of the deficient factor [6]. The mechanisms underlying the haemostatic efficacy of rFVIIa in FVII deficient patients are yet to be elucidated, but probably they cannot be explained by simple replacement of the deficient FVII [23]. Those mechanisms may be related to rFVIIa biding to platelets and to the subsequent local, platelet-mediated delivery of high concentrations of FVIIa to sites of vascular injury, or to platelet activitation. The FVII:C assay might not therefore be accurate for lab monitoring of rFVIIa administration in FVII deficient patients [22-24]. The results of our study indicate that the frequency of rFVIIa administrations in FVII deficient patients undergoing surgical interventions can be safely limited to three injections per day of procedure followed by 1–2 selleck chemicals llc injections on subsequent days. Our mean dose on day of surgery – 50 to 111.1 μg kg−1, and the mean dose on the following days – 18–49.3 did

not differ significantly from those used in other studies [9, 10, 15, 16]. In a recently published article, the total dose of rFVIIa for two patients who underwent total hip and knee replacement was 263 and 241 μg kg−1 respectively [10]. These numbers are lower as compared to our

patients subjected to THR who consumed 412.9 and 444.4 μg kg−1 of rFVIIa respectively. However, both the above-mentioned patients from the Mariani’s study experienced bleeding complications in the perioperative period [10]. In the same study, one patient underwent major orthopaedic surgery for the forearm tumour without any bleeding complications, yet he consumed rFVIIa in the amount comparable to our patients, i.e. 417 μg kg−1 [10]. None of our patients developed excessive bleeding even though FVII:C on the 上海皓元医药股份有限公司 first post-op day returned nearly to the baseline level. It is noteworthy that in contrast to other studies our patients did not receive antifibrinolytics, so the rFVIIa efficacy results obtained in our study were not biased by the use of other haemostatic agents. We are aware of the limitations of our study; the small number of patients and lack of control group. We were also unable to avoid protocol deviation in one case (increased dose of rFVIIa in patient no 04 – see Table 2). Nevertheless, we decided to share our observations with the haemophilia treaters community because there is undoubtedly a need to standardize the treatment protocols for surgical interventions in FVII deficient patients. Our treatment regimen requires further refinement and our aim is to continue data collection in our Centre.

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