{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T14:51:40Z","timestamp":1790175100395,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2016,5,24]],"date-time":"2016-05-24T00:00:00Z","timestamp":1464048000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004702","name":"Baxter International","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004702","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Maintaining haemostasis in surgery is challenging for hereditary rare bleeding disorders in which multi\u2010coagulation\u2010factor concentrates are the only therapeutic option. Hereditary factor X (\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      ) deficiency affects 1:500 000 to 1:1 000 000 individuals, and no specific replacement\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      concentrate has been available. A high\u2010purity, plasma\u2010derived\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      concentrate (pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      ) has been developed for patients with hereditary\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      deficiency.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      Our objective was to assess the safety and efficacy of pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      in subjects with\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      deficiency undergoing surgery.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Subjects with hereditary mild\u2010to\u2010severe\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      deficiency (basal plasma\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      activity [\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      :C] &lt;20\n                      <jats:styled-content style=\"fixed-case\">IU dL<\/jats:styled-content>\n                      <jats:sup>\u22121<\/jats:sup>\n                      ) undergoing surgery received pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      preoperatively to raise\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      :C to 70\u201390\n                      <jats:styled-content style=\"fixed-case\">IU dL<\/jats:styled-content>\n                      <jats:sup>\u22121<\/jats:sup>\n                      and postoperatively to maintain levels &gt;50\n                      <jats:styled-content style=\"fixed-case\">IU dL<\/jats:styled-content>\n                      <jats:sup>\u22121<\/jats:sup>\n                      until the subject was no longer at risk of bleeding due to surgery. Efficacy of pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      was assessed by blood loss during surgery, requirement for blood transfusion, postoperative bleeding from the surgical or other sites, and changes in haemoglobin levels. Safety was assessed by adverse events (\n                      <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>\n                      s), development of inhibitors, and clinically significant changes in laboratory parameters.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Five subjects (aged 14\u201359 years) underwent seven surgical procedures (four major and three minor). Treatment duration was 1\u201315 days. For each procedure, pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      treatment was assessed as \u201cexcellent\u201d in preventing bleeding and achieving haemostasis. No blood transfusions were required, no\n                      <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>\n                      s related to pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      were observed, and no clinically significant trends were found in any laboratory parameters.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      These data demonstrate that pd\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      is safe and effective as replacement therapy in five subjects with mild\u2010to\u2010severe\n                      <jats:styled-content style=\"fixed-case\">FX<\/jats:styled-content>\n                      deficiency undergoing surgery on seven occasions.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.12954","type":"journal-article","created":{"date-parts":[[2016,5,24]],"date-time":"2016-05-24T15:43:30Z","timestamp":1464104610000},"page":"713-720","source":"Crossref","is-referenced-by-count":27,"title":["Experience of a new high\u2010purity factor X concentrate in subjects with hereditary factor X deficiency undergoing surgery"],"prefix":"10.1111","volume":"22","author":[{"given":"M. A.","family":"Escobar","sequence":"first","affiliation":[{"name":"University of Texas Health Science Center and Gulf States Hemophilia and Thrombophilia Center Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Auerswald","sequence":"additional","affiliation":[{"name":"Klinikum Bremen\u2010Mitte Prof\u2010Hess\u2010Kinderklinik Bremen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Austin","sequence":"additional","affiliation":[{"name":"St. George's Hospital University NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. N.","family":"Huang","sequence":"additional","affiliation":[{"name":"University of California San Francisco Benioff Children's Hospital San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Norton","sequence":"additional","affiliation":[{"name":"Bio Products Laboratory Elstree UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. M.","family":"Millar","sequence":"additional","affiliation":[{"name":"Centre for Haematology Hammersmith Campus Imperial College Academic Health Sciences Centre Imperial College London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,5,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2008.01856.x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1225763"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2011.02635.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2006.01303.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2141.1998.00806.x"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.17225\/jhp.00017"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2004-02-0595"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.13058"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12440"},{"key":"e_1_2_10_11_1","first-page":"850","article-title":"Characteristics of a high purity factor X concentrate","volume":"7","author":"Lloyd J","year":"2009","journal-title":"J Thromb Haemost"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12893"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2004.00944.x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/anae.12899"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/105294199277860"},{"issue":"3","key":"e_1_2_10_16_1","first-page":"182","article-title":"Pharmacokinetics, safety and efficacy of a high purity factor X in patients with severe and moderate hereditary factor X deficiency","volume":"18","author":"Alvarez M","year":"2012","journal-title":"Haemophilia"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1985.25185116511.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12262"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhae.12954","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hae.12954","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T19:27:35Z","timestamp":1694892455000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hae.12954"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,5,24]]},"references-count":17,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.1111\/hae.12954"],"URL":"https:\/\/doi.org\/10.1111\/hae.12954","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,5,24]]}}}