{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T07:17:32Z","timestamp":1761895052883},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2010,3,16]],"date-time":"2010-03-16T00:00:00Z","timestamp":1268697600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2010,7]]},"abstract":"<jats:p><jats:bold>Summary.\u2002<\/jats:bold> von Willebrand\u2019s disease (VWD) is an inherited bleeding disorder characterized by deficient levels of or dysfunctional von Willebrand factor (VWF). This phase II\/III open\u2010label, multicentre study evaluated the efficacy and safety of BIOSTATE<jats:sup>\u00ae<\/jats:sup>, a high purity plasma\u2010derived double\u2010virus inactivated FVIII\/VWF concentrate, when used in non\u2010surgical bleeds, surgical procedures and prophylactic therapy in VWD patients for whom desmopressin treatment was deemed ineffective, inadequate or contraindicated. Twenty three patients (7 type 1, 9 type 2 and 7 type 3; 12 male, 11 female), who received FVIII\/VWF concentrate as part of their VWD management, were recruited prospectively between December 2004 and May 2007 from eight centres in Australia and New Zealand. BIOSTATE dosing was based on pre\u2010treatment FVIII:C and\/or VWF:RCo plasma levels and a predetermined dosing guide. Haemostatic efficacy of BIOSTATE was rated as excellent or good for all major and minor surgery events, long\u2010term prophylaxis, and for four of the six assessable non\u2010surgical bleeding events. Blood transfusions were required by two major surgery patients as well as one patient with a non\u2010surgical bleed. The median overall exposure to BIOSTATE across all groups was 8\u2003days, greater in the prophylactic group (range 53\u2013197) compared with major surgery (3\u201324), minor surgery (1\u20138) and non\u2010surgical bleeds (1\u201310). BIOSTATE was shown to be efficacious and well tolerated when treating patients with VWD. This study also provides important insights into dosing regimens with BIOSTATE and the role of monitoring therapy with FVIII:C and VWF:RCo.<\/jats:p>","DOI":"10.1111\/j.1365-2516.2010.02206.x","type":"journal-article","created":{"date-parts":[[2010,3,16]],"date-time":"2010-03-16T06:26:04Z","timestamp":1268720764000},"page":"615-624","source":"Crossref","is-referenced-by-count":34,"title":["Clinical efficacy and safety of the factor VIII\/von Willebrand factor concentrate BIOSTATE<sup>\u00ae<\/sup> in patients with von Willebrand\u2019s disease: a prospective multi\u2010centre study"],"prefix":"10.1111","volume":"16","author":[{"given":"S.","family":"DUNKLEY","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R. I.","family":"BAKER","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"PIDCOCK","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"PRICE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"SELDON","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"SMITH","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"STREET","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"MAHER","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"BARRESE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"STONE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"LLOYD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2010,6,21]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2006.02146.x"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2007.01643.x"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/07853890701513738"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2005-922230"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra040403"},{"key":"e_1_2_7_7_2","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1055\/s-0037-1614448","article-title":"Safety and efficacy of continuous infusion of a combined factor VIII\u2010von Willebrand factor (vWF) concentrate (Haemate\u2010P) in patients with von Willebrand disease","volume":"81","author":"Lubetsky A","year":"1999","journal-title":"Thromb Haemost"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V99.2.450"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1351-8216.2003.00816.x"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.1097\/00001721-200406000-00006"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1351-8216.2003.00809.x"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2007.02562.x"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2007.02588.x"},{"key":"e_1_2_7_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2007.01570.x"},{"key":"e_1_2_7_15_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1613027"},{"key":"e_1_2_7_16_2","doi-asserted-by":"crossref","first-page":"922","DOI":"10.1160\/TH06-09-0495","article-title":"Comparison of the pharmacokinetics of two von Willebrand factor concentrates [Biostate and AHF (High Purity)] in people with von Willebrand disorder","volume":"97","author":"Favaloro EJ","year":"2007","journal-title":"Thromb Haemost"},{"key":"e_1_2_7_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2006.01430.x"},{"key":"e_1_2_7_18_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2006-949668"},{"key":"e_1_2_7_19_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2006-947868"},{"key":"e_1_2_7_20_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.1998.0040s3025.x"},{"key":"e_1_2_7_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2008.01848.x"},{"key":"e_1_2_7_22_2","unstructured":"Australian Haemophilia Centre Directors\u2019 Organisation.Submission to the Department of Health and Ageing Review of Australia\u2019s Plasma Fractionation Arrangements 2005. Available athttp:\/\/www.ahcdo.org.au\/publications\/cid\/2\/parent\/0\/t\/publications\/parent_name\/GeneralPublications. Accessed December 15 2008."},{"key":"e_1_2_7_23_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.2002.00688.x"},{"key":"e_1_2_7_24_2","first-page":"1279","article-title":"Efficacy and safety of factor VIII\/von Willebrand\u2019s factor concentrate (Haemate\u2010P\u00ae) in preventing bleeding during surgery or invasive procedures in patients with von Willebrand disease","volume":"88","author":"Franchini M","year":"2003","journal-title":"Haematologica"},{"key":"e_1_2_7_25_2","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.11124"},{"key":"e_1_2_7_26_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2004.00886.x"},{"key":"e_1_2_7_27_2","doi-asserted-by":"crossref","first-page":"462","DOI":"10.1160\/TH07-08-0527","article-title":"PFA\u2010100 monitoring of von Willebrand factor (VWF) responses to desmopressin (DDAVP) and factor VIII\/VWF concentrate substitution in von Willebrand disease type 1 and 2","volume":"100","author":"Van Vliet HHDM","year":"2008","journal-title":"Thromb Haemost"},{"key":"e_1_2_7_28_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1613227"},{"key":"e_1_2_7_29_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0037-1613225"},{"key":"e_1_2_7_30_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2004.09.009"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1365-2516.2010.02206.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1365-2516.2010.02206.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T02:51:21Z","timestamp":1698634281000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1365-2516.2010.02206.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,6,21]]},"references-count":29,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2010,7]]}},"alternative-id":["10.1111\/j.1365-2516.2010.02206.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1365-2516.2010.02206.x","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,6,21]]}}}