{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T18:28:55Z","timestamp":1770748135387,"version":"3.49.0"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,9,1]],"date-time":"2016-09-01T00:00:00Z","timestamp":1472688000000},"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":[[2016,11]]},"abstract":"<jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>A new fibrinogen concentrate Clottafact<jats:sup>\u00ae<\/jats:sup> was developed according to European guidelines on plasma\u2010derived products. A post\u2010authorization safety study was set up in 2009 as part of the risk management plan. This was a non\u2010interventional, prospective, non\u2010comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real\u2010life medical practice in France.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on\u2010demand treatment, age (&lt;6, &lt;12 and \u226512) and severity of the deficiency.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fourteen patients [1\u201378\u00a0years] were included in 7 centres and followed for 1\u00a0year. Twenty\u2010one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99\u00b75%) and 2 as failures. For the five patients treated on\u2010demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study confirms that the benefit\/risk balance for this fibrinogen concentrate is favourable.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12424","type":"journal-article","created":{"date-parts":[[2016,9,2]],"date-time":"2016-09-02T00:57:44Z","timestamp":1472777864000},"page":"383-390","source":"Crossref","is-referenced-by-count":17,"title":["Post\u2010authorization safety study of Clottafact<sup>\u00ae<\/sup>, a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study"],"prefix":"10.1111","volume":"111","author":[{"given":"C.","family":"N\u00e9grier","sequence":"first","affiliation":[{"name":"Edouard Herriot Hospital Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Rothschild","sequence":"additional","affiliation":[{"name":"Hemophilia Centre Necker Enfants Malades University Hospital \u2010 APHP Paris Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.\u2010Y.","family":"Borg","sequence":"additional","affiliation":[{"name":"Charles Nicolle Hospital Rouen France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Lambert","sequence":"additional","affiliation":[{"name":"Bic\u00eatre Hospital Kremlin Bic\u00eatre France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Claeyssens","sequence":"additional","affiliation":[{"name":"Purpan Hospital Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Sanhes","sequence":"additional","affiliation":[{"name":"Saint\u2010Jean Hospital Perpignan France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Stieltjes","sequence":"additional","affiliation":[{"name":"Cochin Hospital Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Bertrand","sequence":"additional","affiliation":[{"name":"Medical Affairs LFB Biom\u00e9dicaments Les Ulis France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.\u2010H.","family":"Andr\u00e9","sequence":"additional","affiliation":[{"name":"Medical Affairs LFB Biom\u00e9dicaments Les Ulis France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Si\u00e9","sequence":"additional","affiliation":[{"name":"Rangueil Hospital Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Gruel","sequence":"additional","affiliation":[{"name":"Trousseau Hospital Tours France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Z.","family":"Tellier","sequence":"additional","affiliation":[{"name":"Medical Affairs LFB Biom\u00e9dicaments Les Ulis France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,9]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2005.01365.x"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2008.03076.x"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2004.00944.x"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1614361"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0033-1349222"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0049-3848(13)70004-5"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2012.04653.x"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2141.1999.01681.x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2008.01831.x"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.2001.tb03495.x"},{"key":"e_1_2_6_12_1","unstructured":"European Medicines Agency (EMA).Note for Guidance on plasma\u2010derived medicinal products. 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