{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T19:36:20Z","timestamp":1785267380891,"version":"3.55.0"},"reference-count":19,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100016300","name":"Octapharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016300","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Hematology"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Although hemophilia A mainly affects males, carriers (defined as females with hemophilia A, as well as symptomatic or asymptomatic hemophilia A carriers) are at risk of excessive bleeding, particularly during trauma or during surgical procedures. Clinical trials have focused on male patients with severe disease, and data for females are limited. Improved, evidence-based treatment guidelines for management of hemophilia A carriers are required.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives and design:<\/jats:title>\n                    <jats:p>\n                      The NuDIMENSION study is a phase IV, prospective, open-label, single-arm study that will evaluate the perioperative efficacy and safety of simoctocog alfa (Nuwiq\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ), a recombinant factor VIII (FVIII), in women\/girls with hemophilia A undergoing major surgery. The study will be conducted at approximately 15 centers worldwide. Women\/girls aged \u2a7e12\u2009years, with mild or moderate hemophilia A (residual FVIII activity (FVIII:C) \u2a7e1% to &lt;40%) and with no current\/past FVIII inhibitors are eligible. All patients must be scheduled to undergo a major surgical procedure during which simoctocog alfa will be administered.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis:<\/jats:title>\n                    <jats:p>The primary endpoint is overall perioperative hemostatic efficacy (\u201csuccess\u201d or \u201cfailure\u201d) of simoctocog alfa. Hemostatic efficacy will be assessed at the end of surgery and at the end of the postoperative period (i.e., completion of wound healing), with overall adjudication by an Independent Data Monitoring Committee. Safety endpoints will include the incidences of thrombotic events and FVIII inhibitor development. The aim is to recruit 28 patients to achieve 26 evaluable surgeries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics:<\/jats:title>\n                    <jats:p>Ethical approval will be received from institutional review boards\/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>Data from NuDIMENSION will generate much-needed evidence on surgical management of women\/girls with hemophilia A, which will help to enable the development of treatment guidelines specific for such patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration:<\/jats:title>\n                    <jats:p>CT EU 2022-502061-17-00; NCT05936580<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20406207241300040","type":"journal-article","created":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T02:43:32Z","timestamp":1733107412000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Design of an international, phase IV, open-label study of simoctocog alfa in women\/girls with hemophilia A undergoing surgery (NuDIMENSION)"],"prefix":"10.1177","volume":"15","author":[{"given":"Natascha","family":"Marquardt","sequence":"first","affiliation":[{"name":"Institute of Experimental Haematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Langer","sequence":"additional","affiliation":[{"name":"Haemophilia Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3753-0972","authenticated-orcid":false,"given":"Katharina","family":"Holstein","sequence":"additional","affiliation":[{"name":"Haemophilia Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3296-4288","authenticated-orcid":false,"given":"Mar\u00eda Teresa","family":"\u00c1lvarez Rom\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Hematology, Hospital Universitario La Paz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramiro","family":"N\u00fa\u00f1ez V\u00e1zquez","sequence":"additional","affiliation":[{"name":"Hemophilia Unit, Hospital Universitario Virgen del Roc\u00edo, Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Predrag","family":"Milji\u0107","sequence":"additional","affiliation":[{"name":"Clinic of Haematology, University Clinical Centre of Serbia, Belgrade, Serbia Faculty of Medicine, University of Belgrade, Belgrade, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Drillaud","sequence":"additional","affiliation":[{"name":"Haemophilia Treatment Centre, University Hospital of Nantes and French Reference Centre on Haemophilia, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Ardillon","sequence":"additional","affiliation":[{"name":"Haemophilia Treatment Centre CRC-MHC, University Hospital of Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna-Elina","family":"Lehtinen","sequence":"additional","affiliation":[{"name":"Coagulation Disorders Unit, Department of Hematology, Comprehensive Cancer Center, Helsinki University Hospital and Helsinki University, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita Carlotta","family":"Santoro","sequence":"additional","affiliation":[{"name":"Hemostasis and Thrombosis Unit, Azienda Ospedaliero Universitaria Dulbecco, Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariasanta","family":"Napolitano","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Siragusa","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gillian","family":"Gidley","sequence":"additional","affiliation":[{"name":"Haemophilia Centre, St James\u2019s University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Jansen","sequence":"additional","affiliation":[{"name":"Octapharma Pharmazeutika Produktionsgesellschaft mbH, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigurd","family":"Knaub","sequence":"additional","affiliation":[{"name":"Octapharma AG, Lachen, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Oldenburg","sequence":"additional","affiliation":[{"name":"Institute of Experimental Haematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Venusberg Campus 1, Geb\u00e4ude 43, Bonn 53127, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,12,1]]},"reference":[{"key":"bibr1-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"bibr2-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/jth.15397"},{"key":"bibr3-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14094"},{"key":"bibr4-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14379"},{"key":"bibr5-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14535"},{"key":"bibr6-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12690"},{"key":"bibr7-20406207241300040","author":"National Hemophilia Foundation","year":"2021","journal-title":"Medical and Scientific Advisory Council (MASAC) document #265: MASAC guidelines for pregnancy and perinatal management of women with inherited bleeding disorders and carriers of hemophilia A or B"},{"key":"bibr8-20406207241300040","unstructured":"United Kingdom Haemophilia Centre Doctors\u2019 Organisation (UKHCDO). UKHCDO Annual Report 2022 & Bleeding Disorder Statistics for the Financial Year 2021\/22: a report from the UKHCDO and NHD, 2022. https:\/\/www.ukhcdo.org\/wp-content\/uploads\/2022\/12\/UKHCDO-Annual-Report-2022-2021-22-Data.pdf (accessed 8 March 2023)."},{"key":"bibr9-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1097\/MBC.0000000000000083"},{"key":"bibr10-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-09-3879"},{"key":"bibr11-20406207241300040","first-page":"535","volume":"16","author":"Benson G","year":"2018","journal-title":"Blood Transfus"},{"key":"bibr12-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14403"},{"key":"bibr13-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14750"},{"key":"bibr14-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1177\/2040620719858471"},{"key":"bibr15-20406207241300040","unstructured":"Octapharma AG, Lachen, Switzerland. Nuwiq\n                      \u00ae\n                      Summary of product characteristics. Revised November 2022."},{"key":"bibr16-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13351"},{"key":"bibr17-20406207241300040","unstructured":"Octapharma AG, Lachen, Switzerland. Nuwiq\n                      \u00ae\n                      Prescribing information. Revised June 2021."},{"key":"bibr18-20406207241300040","unstructured":"Centers for Disease Control and Prevention. Community counts, https:\/\/www.cdc.gov\/hemophilia-community-counts\/php\/data-research\/2024-march-factor-viii-and-factor-ix.html (2024, accessed 11 November 2024)."},{"key":"bibr19-20406207241300040","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14232"}],"container-title":["Therapeutic Advances in Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20406207241300040","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20406207241300040","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20406207241300040","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:17:24Z","timestamp":1777591044000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20406207241300040"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":19,"alternative-id":["10.1177\/20406207241300040"],"URL":"https:\/\/doi.org\/10.1177\/20406207241300040","relation":{},"ISSN":["2040-6207","2040-6215"],"issn-type":[{"value":"2040-6207","type":"print"},{"value":"2040-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"article-number":"20406207241300040"}}