{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T02:28:25Z","timestamp":1761964105453},"reference-count":46,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2005,7,22]],"date-time":"2005-07-22T00:00:00Z","timestamp":1121990400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2005,9]]},"abstract":"<jats:p><jats:bold>BACKGROUND:<\/jats:bold> Off\u2010label use of recombinant factor VIIa (rFVIIa) occurs despite minimal data. The purpose of this study was to describe prescribing practices and clinical outcomes for off\u2010label rFVIIa use.<\/jats:p><jats:p><jats:bold>STUDY DESIGN AND METHODS:<\/jats:bold> A retrospective, multicenter chart audit of 315 nonhemophiliac patients was performed.<\/jats:p><jats:p><jats:bold>RESULTS:<\/jats:bold> Off\u2010label indications included prevention of bleeding primarily related to procedural manipulation in 37.8\u2003percent of patients and treatment of bleeding in 62.2\u2003percent of patients. Baseline coagulopathy was present in 79.7\u2003percent of patients. Prescriber specialty varied. The median doses for prevention and treatment were 75.6 and 89.4\u2003\u00b5g per kg, respectively (p\u2003=\u20030.0006). The international normalized ratio (INR) decreased (p\u2003&lt;\u20030.0001) from baseline in both groups. Transfusions of blood products were provided to 85.1\u2003percent of patients before rFVIIa administration with considerable practice variation. Few patients received other procoagulant agents. In the prevention group, 14.3\u2003percent of patients bled within 6\u2003hours of their procedure. No variable was independently associated with bleeding prevention. In the treatment group, 52.6\u2003percent of patients stopped bleeding within 6\u2003hours of rFVIIa administration. The only independent variable associated with bleeding cessation was an arterial pH value of less than 7.20, which was a negative predictor (odds ratio, 0.207; 95% confidence interval, 0.084\u20100.507). Possible rFVIIa\u2010associated adverse events occurred in 9.8\u2003percent of patients and primarily involved undesirable clotting. No variable was independently associated with adverse events.<\/jats:p><jats:p><jats:bold>CONCLUSIONS:<\/jats:bold> Off\u2010label use of rFVIIa includes prevention and treatment of bleeding. rFVIIa is associated with INR reduction. Bleeding is rare with prophylactic rFVIIa but the cessation of bleeding is less than reported in the literature and may be related to pH. Possible adverse events are related to undesirable clotting.<\/jats:p>","DOI":"10.1111\/j.1537-2995.2005.00548.x","type":"journal-article","created":{"date-parts":[[2006,8,22]],"date-time":"2006-08-22T10:09:23Z","timestamp":1156241363000},"page":"1434-1442","source":"Crossref","is-referenced-by-count":60,"title":["A multicenter assessment of recombinant factor VIIa off\u2010label usage: clinical experiences and associated outcomes"],"prefix":"10.1111","volume":"45","author":[{"given":"Robert","family":"MacLaren","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura A.","family":"Weber","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helga","family":"Brake","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melinda A.","family":"Gardner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Tanzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2005,7,22]]},"reference":[{"key":"e_1_2_7_2_2","volume-title":"NovoSeven prescribing information [Internet].","year":"2004"},{"key":"e_1_2_7_3_2","first-page":"S7","article-title":"Recombinant activated factor VII: its mechanism of action and role in the control of hemorrhage","volume":"49","author":"Allen GA","year":"2002","journal-title":"Can J Anaesth"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2004.04052.x"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.blre.2003.12.003"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1586\/14779072.2.5.661"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0037-1963(01)90147-7"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00017.x"},{"key":"e_1_2_7_9_2","first-page":"408","article-title":"Translating guidelines into practice: a systematic review of the theoretic concepts, practical experiences and research evidence in the adoption of clinical practice guidelines","volume":"157","author":"Davis DA","year":"1997","journal-title":"CMAJ"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-137-11-200212030-00009"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1227\/01.NEU.0000068830.54968.A8"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200307000-00007"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1186\/cc2602"},{"key":"e_1_2_7_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200004001-00018"},{"key":"e_1_2_7_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200104000-00005"},{"key":"e_1_2_7_16_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200004001-00014"},{"key":"e_1_2_7_17_2","doi-asserted-by":"publisher","DOI":"10.1097\/00005176-200309000-00013"},{"key":"e_1_2_7_18_2","doi-asserted-by":"publisher","DOI":"10.1053\/jlts.2003.50017"},{"key":"e_1_2_7_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(97)70013-1"},{"key":"e_1_2_7_20_2","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2002.34164"},{"key":"e_1_2_7_21_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200206000-00006"},{"key":"e_1_2_7_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200102150-00011"},{"key":"e_1_2_7_23_2","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2002.31771"},{"key":"e_1_2_7_24_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.07.015"},{"key":"e_1_2_7_25_2","doi-asserted-by":"publisher","DOI":"10.1080\/003655201750422701"},{"key":"e_1_2_7_26_2","first-page":"S15","article-title":"Possible role of recombinant activated factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma","volume":"49","author":"Martinowitz U","year":"2002","journal-title":"Can J Anaesth"},{"key":"e_1_2_7_27_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.TA.0000140646.66852.AB"},{"key":"e_1_2_7_28_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200306001-00009"},{"key":"e_1_2_7_29_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200312000-00004"},{"key":"e_1_2_7_30_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.0041-1132.2003.00577.x"},{"issue":"1","key":"e_1_2_7_31_2","first-page":"159","article-title":"Clinical experience with recombinant factor VIIa in patients with thrombocytopenia","volume":"26","author":"Kristensen J","year":"1996","journal-title":"Haemostasis"},{"key":"e_1_2_7_32_2","unstructured":"Von HeymannC KastrupM RedlichU KoxWJ SpiesCD.Experiences with recombinant activated FII (rFVIIa) for refractory bleeding after cardiac surgery\u2014a retrospective analysis.Anesthesiology[accessed 2004 Oct 12]. 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