{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T05:03:08Z","timestamp":1761541388592,"version":"3.37.3"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,12,13]],"date-time":"2017-12-13T00:00:00Z","timestamp":1513123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact<jats:sup>\u00ae<\/jats:sup> in acquired fibrinogen deficiency in real\u2010life medical practice in France.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>One hundred and fifty patients were planned for 28\u00a0days of prospective follow\u2010up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred and fifty\u2010six patients (16\u201387\u00a0years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological\/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow\u2010up time was 18\u00b79\u00a0\u00b1\u00a012\u00b73\u00a0days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four\u2010site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73\u00b76%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4\u00b74%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Clottafact<jats:sup>\u00ae<\/jats:sup> safety profile observed during the study matched the known profile of fibrinogen during use.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12624","type":"journal-article","created":{"date-parts":[[2017,12,14]],"date-time":"2017-12-14T03:12:42Z","timestamp":1513221162000},"page":"120-127","source":"Crossref","is-referenced-by-count":10,"title":["Postauthorization safety study of Clottafact<sup>\u00ae<\/sup>, a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study"],"prefix":"10.1111","volume":"113","author":[{"given":"C.","family":"N\u00e9grier","sequence":"first","affiliation":[{"name":"Edouard Herriot Hospital Lyon 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