{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T10:27:53Z","timestamp":1744453673478,"version":"3.37.3"},"reference-count":33,"publisher":"Georg Thieme Verlag KG","issue":"08","license":[{"start":{"date-parts":[[2022,5,31]],"date-time":"2022-05-31T00:00:00Z","timestamp":1653955200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"LFB"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thromb Haemost"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Background\u2003A plasma-derived factor VIII product (pdFVIII; Factane 100 or 200\u2009IU\/mL) and a plasma-derived von Willebrand factor product (pdVWF; Wilfactin 100\u2009IU\/mL) are approved for replacement therapy by intravenous bolus injections in hemophilia A (HA) and von Willebrand disease (VWD), respectively. However, in situations requiring intensive treatment, continuous infusion (CI) may be desirable to better control target plasma factor levels.<\/jats:p><jats:p>\n          Aim\u2003To evaluate the perioperative hemostatic efficacy and safety of these concentrates administered by CI.<\/jats:p><jats:p>\n          Methods\u2003Three phase III trials were conducted. Adults with HA (FVIII:C\u2009&lt;\u20091%) (studies 1 and 2) or VWD (VWF:RCo\u2009&lt;\u200920%) (Study 3) received a preoperative bolus followed by CI of undiluted concentrate for at least 6 days. Bolus doses and CI rates were based on individual recovery and clearance, respectively. The initial infusion rate had to be higher for 48\u2009hours for HA and 24\u2009hours for VWD patients to anticipate potential fluctuations of factor concentrations during major surgery. Target levels of FVIII:C in HA and VWF:RCo in VWD were 80 and 70\u2009IU\/dL, respectively. Efficacy was assessed using a global hemostatic efficacy score.<\/jats:p><jats:p>\n          Results\u2003Studies 1, 2, and 3 included 12, 4, and 6 patients, respectively. Efficacy outcomes were excellent\/good in all 22 major surgeries including 18 orthopedic procedures. Most daily measured FVIII and VWF levels (92%) were on target. No safety concerns, thrombotic events, or inhibitors were identified.<\/jats:p><jats:p>\n          Conclusion\u2003pdFVIII and pdVWF administered by CI represent an effective and safe alternative to bolus injections in patients with severe HA or VWD undergoing surgery.<\/jats:p>","DOI":"10.1055\/a-1865-6978","type":"journal-article","created":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T06:27:41Z","timestamp":1654064861000},"page":"1304-1313","source":"Crossref","is-referenced-by-count":2,"title":["Continuous Infusion of Factor VIII and von Willebrand Factor in Surgery: Trials with pdFVIII LFB or pdVWF LFB in Patients with Bleeding Disorders"],"prefix":"10.1055","volume":"122","author":[{"given":"Jerzy","family":"Windyga","sequence":"additional","affiliation":[{"name":"Department of Hemostasis Disorders and Internal Medicine, Laboratory of Hemostasis and Metabolic Diseases, Institute of Hematology and Transfusion Medicine, Warsaw, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beno\u00eet","family":"Guillet","sequence":"additional","affiliation":[{"name":"Department of Hemophilia Treatment, CHU Rennes, University of Rennes, Inserm, EHESP, IRSET (Institut de recherche en sant\u00e9, environnement et travail) - UMR_S 1085, F-35000 Rennes, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3103-1737","authenticated-orcid":false,"given":"Lucia","family":"Rugeri","sequence":"additional","affiliation":[{"name":"Hematology Division, Hemophilia Comprehensive Care Center, H\u00f4pital Louis Pradel, Hospices Civils de Lyon, Bron, Universit\u00e9 Claude Bernard, Lyon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Fournel","sequence":"additional","affiliation":[{"name":"Hematology Department, CHRU Besan\u00e7on, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ewa","family":"Stefanska-Windyga","sequence":"additional","affiliation":[{"name":"Department of Hemostasis Disorders and Internal Medicine, Laboratory of Hemostasis and Metabolic Diseases, Institute of Hematology and Transfusion Medicine, Warsaw, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Val\u00e9rie","family":"Chamouard","sequence":"additional","affiliation":[{"name":"Hematology Division, Hemophilia Comprehensive Care Center, H\u00f4pital Louis Pradel, Hospices Civils de Lyon, Bron, Universit\u00e9 Claude Bernard, Lyon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonia","family":"Pujol","sequence":"additional","affiliation":[{"name":"Clinical Development, Laboratoire fran\u00e7ais du Fractionnement et des Biotechnologies (LFB), Les Ulis, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7796-1569","authenticated-orcid":false,"given":"C\u00e9line","family":"Henriet","sequence":"additional","affiliation":[{"name":"Clinical Development, Laboratoire fran\u00e7ais du Fractionnement et des Biotechnologies (LFB), Les Ulis, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7oise","family":"Bridey","sequence":"additional","affiliation":[{"name":"Formerly Clinical Development, LFB, Les Ulis, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claude","family":"N\u00e9grier","sequence":"additional","affiliation":[{"name":"Hematology Division, Hemophilia Comprehensive Care Center, H\u00f4pital Louis Pradel, Hospices Civils de Lyon, Bron, Universit\u00e9 Claude Bernard, Lyon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2022,7,24]]},"reference":[{"issue":"242","key":"ref1","first-page":"60","article-title":"Surgical management of advanced hemophilic arthropathy. 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Schulman","year":"2000","journal-title":"Semin Thromb Hemost"},{"issue":"05","key":"ref39","doi-asserted-by":"crossref","first-page":"758","DOI":"10.1111\/hae.12185","article-title":"Quantification of perioperative changes in von Willebrand factor and factor VIII during elective orthopaedic surgery in normal individuals","volume":"19","author":"A Kahlon","year":"2013","journal-title":"Haemophilia"},{"issue":"07","key":"ref40","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1056\/NEJM200008173430702","article-title":"High plasma levels of factor VIII and the risk of recurrent venous thromboembolism","volume":"343","author":"P A Kyrle","year":"2000","journal-title":"N Engl J Med"}],"container-title":["Thrombosis and 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