[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373740":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":49,"locations":55,"responsibleParty":238,"collaborators":241,"id":247,"slug":248,"hasResults":249,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":249,"sex":255,"minAge":256,"maxAge":10,"enrollmentInfo":257,"targetDuration":10,"studyType":260,"phases":10,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},{"fullName":5,"class":6},"University of Washington","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Corrector",null,"Patients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.",[13,14,15],"Other: Use of a postpartum diary and additional blood draws","Drug: VWF replacement therapy with Wilate","Drug: Tranexamic acid",{"label":17,"type":10,"description":18,"interventionNames":19},"Corrector","Patients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.",[15,20],"Other: Use of a postpartum diary and additional blood draws.",[22,26,31,35],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Use of a postpartum diary and additional blood draws","A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.\n\nSeveral blood draws additional to what is expected for routine clinical care will also be taken.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DRUG","VWF replacement therapy with Wilate","This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are \\\u003C100% in the third trimester of pregnancy",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Tranexamic acid","This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD",[17,9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Use of a postpartum diary and additional blood draws.","A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.\n\nSeveral blood draws additional to what is expected for routine clinical care will also be taken.",[17],[40,43,46],{"name":41,"affiliation":5,"role":42},"Jill M Johnsen, M.D.","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":42},"Barbara A Konkle, M.D.","Washington Center for Bleeding Disorders",{"name":47,"affiliation":48,"role":42},"Peter A Kouides, M.D.","Mary M. Gooley Hemophilia Center",[50],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},"Central Study Contact","CONTACT","919-792-3740","VIP.Study@ergomedgroup.com",[56,77,94,111,128,144,161,172,188,205,222],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"University of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-104.83192,39.72943,{"lat":68,"lon":67},[71,75],{"name":72,"role":52,"phone":73,"phoneExt":10,"email":74},"Julie Smith","303-724-6187","julie.smith@cuanschutz.edu",{"name":76,"role":42,"phone":10,"phoneExt":10,"email":10},"Genevieve Moyer, MD",{"facility":78,"status":58,"city":79,"state":80,"zip":81,"country":62,"countryCode":63,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Yale University","New Haven","Connecticut","06510",{"type":65,"coordinates":83},[84,85],-72.92816,41.30815,{"lat":85,"lon":84},[88,92],{"name":89,"role":52,"phone":90,"phoneExt":10,"email":91},"Evangelia Louizos","203-843-6358","e.louizos@yale.edu",{"name":93,"role":42,"phone":10,"phoneExt":10,"email":10},"Robert Bona, MD",{"facility":95,"status":58,"city":96,"state":97,"zip":98,"country":62,"countryCode":63,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"University of Miami","Miami","Florida","33136",{"type":65,"coordinates":100},[101,102],-80.19366,25.77427,{"lat":102,"lon":101},[105,109],{"name":106,"role":52,"phone":107,"phoneExt":10,"email":108},"Jemima Duroseau, BSN, RN, MPH","305-243-0796","jxp431@med.miami.edu",{"name":110,"role":42,"phone":10,"phoneExt":10,"email":10},"Michael Paidas, MD",{"facility":112,"status":58,"city":113,"state":114,"zip":115,"country":62,"countryCode":63,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Emory University","Atlanta","Georgia","30308",{"type":65,"coordinates":117},[118,119],-84.38798,33.749,{"lat":119,"lon":118},[122,126],{"name":123,"role":52,"phone":124,"phoneExt":10,"email":125},"Lucy Sanchez","407-879-4446","lucy.sanchez@emory.edu",{"name":127,"role":42,"phone":10,"phoneExt":10,"email":10},"Christine Kempton, MD, MSc",{"facility":129,"status":58,"city":130,"state":131,"zip":132,"country":62,"countryCode":63,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Bleeding & Clotting Disorders Institute","Peoria","Illinois","61615",{"type":65,"coordinates":134},[135,136],-89.58899,40.69365,{"lat":136,"lon":135},[139,143],{"name":140,"role":52,"phone":141,"phoneExt":10,"email":142},"Jonathan Roberts, MD","309-692-5337","jroberts@ilbcdi.org",{"name":140,"role":42,"phone":10,"phoneExt":10,"email":10},{"facility":145,"status":58,"city":146,"state":147,"zip":148,"country":62,"countryCode":63,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders","New Orleans","Louisiana","70112",{"type":65,"coordinates":150},[151,152],-90.07507,29.95465,{"lat":152,"lon":151},[155,159],{"name":156,"role":52,"phone":157,"phoneExt":10,"email":158},"Melody Benton, MPH,MAS,CCRP","504-988-3596","mbenton@tulane.edu",{"name":160,"role":42,"phone":10,"phoneExt":10,"email":10},"Maissaa Janbain, MD",{"facility":162,"status":163,"city":164,"state":165,"zip":166,"country":62,"countryCode":63,"cosmosGeoPoint":167,"geoPoint":171,"contacts":10},"Oregon Health & Science University","WITHDRAWN","Portland","Oregon","97239",{"type":65,"coordinates":168},[169,170],-122.67621,45.52345,{"lat":170,"lon":169},{"facility":173,"status":58,"city":174,"state":175,"zip":176,"country":62,"countryCode":63,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"The Pennsylvania State University","Hershey","Pennsylvania","17033",{"type":65,"coordinates":178},[179,180],-76.65025,40.28592,{"lat":180,"lon":179},[183,186],{"name":184,"role":52,"phone":10,"phoneExt":10,"email":185},"Cynthia Campbell-Baird","cbaird@pennstatehealth.psu.edu",{"name":187,"role":42,"phone":10,"phoneExt":10,"email":10},"Peter Cygan, MD",{"facility":189,"status":58,"city":190,"state":191,"zip":192,"country":62,"countryCode":63,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Vanderbilt University","Nashville","Tennessee","27232",{"type":65,"coordinates":194},[195,196],-86.78444,36.16589,{"lat":196,"lon":195},[199,203],{"name":200,"role":52,"phone":201,"phoneExt":10,"email":202},"Jadeah Jackson","615-327-7184","jadeah.b.jackson@vumc.org",{"name":204,"role":42,"phone":10,"phoneExt":10,"email":10},"Shannon Walker, MD",{"facility":206,"status":58,"city":207,"state":208,"zip":209,"country":62,"countryCode":63,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"University of Utah","Salt Lake City","Utah","84108",{"type":65,"coordinates":211},[212,213],-111.89105,40.76078,{"lat":213,"lon":212},[216,220],{"name":217,"role":52,"phone":218,"phoneExt":10,"email":219},"Emily Powers","801-587-0640","emily.powers@hsc.utah.edu",{"name":221,"role":42,"phone":10,"phoneExt":10,"email":10},"Ming Lim, MBBCh, MS",{"facility":45,"status":58,"city":223,"state":224,"zip":225,"country":62,"countryCode":63,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Seattle","Washington","98104",{"type":65,"coordinates":227},[228,229],-122.33207,47.60621,{"lat":229,"lon":228},[232,236],{"name":233,"role":52,"phone":234,"phoneExt":10,"email":235},"Sarah Ruuska, MPH","206-689-6193","sarah.ruuska@WACBD.org",{"name":237,"role":42,"phone":10,"phoneExt":10,"email":10},"Allison Wheeler, MD",{"type":42,"investigatorFullName":239,"investigatorTitle":240,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jill Johnsen","Professor, School of Medicine: Hematology and Oncology",[242,245],{"name":243,"class":244},"Ergomed","INDUSTRY",{"name":246,"class":244},"Octapharma","100373740","von-willebrand-factor-in-pregnancy-vip-study-100373740",false,"NCT04146376","Von Willebrand Factor in Pregnancy (VIP) Study","Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth","VIP","Inclusion Criteria:\n\n* von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD\n\nor\n\n* A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:\n* Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector\n* Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group\n\nWritten informed consent from the patient prepartum, before gestational week 39\n\nExclusion Criteria:\n\n* Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction\n* Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders\n* Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy\n* Age less than 18 years\n* Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments","FEMALE","18 Years",{"count":258,"type":259},110,"ESTIMATED","OBSERVATIONAL","In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding.\n\nThis is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.",[263],"Von Willebrand Diseases",[265,266,267],"von Willebrand Disease","von Willebrand Factor","postpartum hemorrhage","2025-12-10",{"date":270,"type":271},"2025-12-18","ACTUAL",{"date":273,"type":271},"2019-10-12",{"date":275,"type":259},"2026-12",{"name":5,"class":6},11]