{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:22:51Z","timestamp":1790864571812,"version":"4.1.0"},"reference-count":55,"publisher":"American Society of Hematology","issue":"1","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2010,12,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Recombinant human factor VIIa (rFVIIa) is approved by the US Food and Drug Administration for use in the setting of hemorrhage associated with factor VIII or factor IX inhibitors in patients with congenital or acquired hemophilia. This indication represents only a small number of bleeding conditions. Since it became available, rFVIIa has been increasingly used in the management of off-label indications, ranging from emergent hemostasis in traumatic hemorrhage to prophylactic hemostasis in patients undergoing major surgery. Prominent off-label indications include the management of patients with coagulopathies, such as occurs in trauma patients experiencing massive and uncontrolled hemorrhage, and in patients undergoing cardiovascular surgery with cardiopulmonary bypass. Other occasions for use occur in patients with intact coagulation systems, with nontraumatic intracranial hemorrhage being the most common in this group. Uncertainties regarding the efficacy and safety associated with use of rFVIIa in these off-label scenarios have led to evidence-based assessments of patient outcomes, including mortality, the rate of thromboembolic adverse events, and posttreatment functional status. We review the evidence regarding the efficacy and safety of this important, but controversial, hemostatic agent in the off-label setting.<\/jats:p>","DOI":"10.1182\/asheducation-2010.1.153","type":"journal-article","created":{"date-parts":[[2011,1,16]],"date-time":"2011-01-16T19:08:48Z","timestamp":1295204928000},"page":"153-159","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":35,"title":["Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting"],"prefix":"10.1182","volume":"2010","author":[{"given":"Aaron C.","family":"Logan","sequence":"first","affiliation":[{"name":"Department of Medicine, Divisions of Hematology and"},{"name":"Blood and Marrow Transplantation, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence T.","family":"Goodnough","sequence":"additional","affiliation":[{"name":"Department of Medicine, Divisions of Hematology 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warfarin","volume":"96","author":"Deveras","year":"2000","journal-title":"Blood"},{"key":"2019111716104581000_B30","doi-asserted-by":"crossref","first-page":"884","DOI":"10.7326\/0003-4819-137-11-200212030-00009","article-title":"Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate","volume":"137","author":"Deveras","year":"2002","journal-title":"Ann Intern Med"},{"key":"2019111716104581000_B31","doi-asserted-by":"crossref","first-page":"737","DOI":"10.3171\/jns.2003.98.4.0737","article-title":"The use of recombinant activated factor VII to reverse warfarin-induced anticoagulation in patients with hemorrhages in the central nervous system: preliminary findings","volume":"98","author":"Lin","year":"2003","journal-title":"J Neurosurg"},{"key":"2019111716104581000_B32","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1385\/NCC:2:3:263","article-title":"Use of recombinant factor VIIa in patients with warfarin-associated intracranial 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Med"},{"key":"2019111716104581000_B38","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1001\/jama.295.3.293","article-title":"Thromboembolic adverse events after use of recombinant human coagulation factor VIIa","volume":"295","author":"O'Connell","year":"2006","journal-title":"JAMA"},{"key":"2019111716104581000_B39","doi-asserted-by":"crossref","first-page":"564","DOI":"10.1097\/TA.0b013e318031afc2","article-title":"Thromboembolic complications associated with factor VII administration","volume":"62","author":"Thomas","year":"2007","journal-title":"J Trauma"},{"key":"2019111716104581000_B40","doi-asserted-by":"crossref","first-page":"850","DOI":"10.1161\/STROKEAHA.107.493601","article-title":"Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage","volume":"39","author":"Diringer","year":"2008","journal-title":"Stroke"},{"key":"2019111716104581000_B41","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1016\/j.athoracsur.2006.10.033","article-title":"Recombinant activated factor VII in cardiac surgery: a systematic review","volume":"83","author":"Warren","year":"2007","journal-title":"Ann Thorac Surg"},{"key":"2019111716104581000_B42","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1097\/SLA.0b013e318176c4ec","article-title":"Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials","volume":"248","author":"Hsia","year":"2008","journal-title":"Ann Surg"},{"key":"2019111716104581000_B43","doi-asserted-by":"crossref","first-page":"1325","DOI":"10.1111\/j.1537-2995.2004.04052.x","article-title":"Transfusion medicine service policies for recombinant factor VIIa administration","volume":"44","author":"Goodnough","year":"2004","journal-title":"Transfusion"},{"key":"2019111716104581000_B44","doi-asserted-by":"crossref","first-page":"1434","DOI":"10.1111\/j.1537-2995.2005.00548.x","article-title":"A multicenter assessment of recombinant factor VIIa off-label usage: clinical experiences and associated outcomes","volume":"45","author":"MacLaren","year":"2005","journal-title":"Tranfusion"},{"key":"2019111716104581000_B45","first-page":"218","article-title":"An evalutation of off-label use of recombinant activated human factor VII (NovoSeven): patient characteristics, utilization trends, and outcomes from an electronic database of US academic health centers","volume":"32","author":"Magnetti","year":"2007","journal-title":"Pharm Ther"},{"key":"2019111716104581000_B46","doi-asserted-by":"crossref","first-page":"S68","DOI":"10.1053\/j.seminhematol.2008.03.003","article-title":"On-label versus off-label use of recombinant activated factor VII: a comprehensive review of use in two Canadian centers","volume":"45","author":"Carcao","year":"2008","journal-title":"Semin Hematol"},{"key":"2019111716104581000_B47","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1002\/pbc.21375","article-title":"A comprehensive review of rFVIIa use in a tertiary care pediatric center","volume":"50","author":"Heller","year":"2008","journal-title":"Pediatr Blood Cancer"},{"key":"2019111716104581000_B48","doi-asserted-by":"crossref","first-page":"518","DOI":"10.1111\/j.1365-2516.2007.01490.x","article-title":"Utilization of recombinant activated factor VII in southern Ontario in 85 patients with and without haemophilia","volume":"13","author":"Webert","year":"2007","journal-title":"Haemophilia"},{"key":"2019111716104581000_B49","unstructured":"Yank\n              V\n            \n            \n              Tuohy\n              CV\n            \n            \n              Logan\n              AC\n            \n            \n          \n       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Comparative effectiveness review\n          Agency for Healthcare Research and Quality Web site\n          Accessed June 16, 2010\n          \n            http:\/\/www.effectivehealthcare.ahrq.gov\/reports\/final.cfm"},{"key":"2019111716104581000_B50","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1111\/j.1365-2257.2006.00815.x","article-title":"Recombinant factor VIIa: unregulated continuous use in patients with bleeding and coagulopathy does not alter mortality and outcome","volume":"28","author":"Ganguly","year":"2006","journal-title":"Clin Lab Haem"},{"key":"2019111716104581000_B51","doi-asserted-by":"crossref","first-page":"160S","DOI":"10.1378\/chest.08-0670","article-title":"Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines","volume":"133","author":"Ansell","year":"2008","journal-title":"Chest"},{"key":"2019111716104581000_B52","doi-asserted-by":"crossref","first-page":"R120","DOI":"10.1186\/cc5026","article-title":"Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding\u2014a European perspective","volume":"10","author":"Vincent","year":"2006","journal-title":"Crit Care"},{"key":"2019111716104581000_B53","unstructured":"Top 200 drugs used in hospitals in 2007\n          Drug Topics Web site\n          Accessed April 19, 2010\n          \n            http:\/\/drugtopics.modernmedicine.com\/drugtopics\/data\/articlestandard\/drugtopics\/262008\/526563\/article.pdf"},{"key":"2019111716104581000_B54","unstructured":"Novo Nordisk\n          RT coagulation factor VIIa (recombinant) package insert\n          Food and Drug Administration Web site\n          Accessed April 19, 2010\n          \n            http:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/BloodBloodProducts\/ApprovedProducts\/LicensedProductsBLAs\/FractionatedPlasmaProducts\/ucm056954.pdf"},{"key":"2019111716104581000_B55","doi-asserted-by":"crossref","first-page":"1791","DOI":"10.1056\/NEJMoa1006221","article-title":"Safety of recombinant activated factor VII in randomized clinical trials","volume":"363","author":"Levi","year":"2010","journal-title":"N Engl J Med"}],"container-title":["Hematology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/ashpublications.org\/hematology\/article-pdf\/2010\/1\/153\/1492634\/bep00110000153.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/ashpublications.org\/hematology\/article-pdf\/2010\/1\/153\/1492634\/bep00110000153.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,11,17]],"date-time":"2019-11-17T21:11:08Z","timestamp":1574025068000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/hematology\/article\/2010\/1\/153\/96378\/Recombinant-Factor-VIIa-An-Assessment-of-Evidence"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,12,4]]},"references-count":55,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2010,12,4]]}},"URL":"https:\/\/doi.org\/10.1182\/asheducation-2010.1.153","relation":{},"ISSN":["1520-4391","1520-4383"],"issn-type":[{"value":"1520-4391","type":"print"},{"value":"1520-4383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,12,4]]}}}