{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T09:11:11Z","timestamp":1791882671794,"version":"4.3.4"},"reference-count":86,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Appl Thromb Hemost"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:p>\n                    Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP\n                    <jats:sup>\u00ae<\/jats:sup>\n                    \/Haemocomplettan\n                    <jats:sup>\u00ae<\/jats:sup>\n                    P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986\u2013June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14\/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and\/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.\n                  <\/jats:p>","DOI":"10.1177\/10760296241254106","type":"journal-article","created":{"date-parts":[[2024,5,28]],"date-time":"2024-05-28T02:14:42Z","timestamp":1716862482000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Long-Term Safety Analysis of a  Fibrinogen Concentrate (RiaSTAP\n                    <sup>\u00ae<\/sup>\n                    \/Haemocomplettan\n                    <sup>\u00ae<\/sup>\n                    P)"],"prefix":"10.1177","volume":"30","author":[{"given":"Niels","family":"Rahe-Meyer","sequence":"first","affiliation":[{"name":"Department for Anaesthesiology and Intensive Care Medicine, Franziskus Hospital Bielefeld, Bielefeld, Germany"},{"name":"Department for Anaesthesiology and 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