[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627863":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":107,"collaborators":109,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":10,"enrollmentInfo":122,"targetDuration":125,"studyType":126,"phases":10,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Bleeding Disorder of Unknown Cause",null,"This cohort consists of patients aged ≥12 years presenting with a clinically relevant increased bleeding tendency, as determined by a medical specialist or indicated by an elevated ISTH Bleeding Assessment Tool (ISTH-BAT) score, who remain without a definitive hemostatic diagnosis after extensive laboratory evaluation. These individuals are classified as having a bleeding disorder of unknown cause (BDUC).\n\nThe bleeding phenotype in this cohort is generally similar to that of patients with established coagulation disorders. Participants frequently experience an increased risk of bleeding during daily life (e.g., heavy menstrual bleeding) and during medical procedures such as surgery, dental interventions, or childbirth, as well as following trauma.\n\nIn this study, participants will undergo blood sampling for advanced hemostasis and genetic analysis, complete questionnaires, and be followed longitudinally to assess the impact of bleeding on health-related quality of life.",[13],{"name":14,"affiliation":5,"role":15},"F.C.J.I. Heubel-Moenen, Dr.","PRINCIPAL_INVESTIGATOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Dr. F.C.J.I. Heubel-Moenen","CONTACT","+31 (0)43 3876543","floor.moenen@mumc.nl",[23,37,49,59,69,79,89,98],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":10},"Radboud University Medical Center","NOT_YET_RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":32,"coordinates":33},"Point",[34,35],5.85278,51.8425,{"lat":35,"lon":34},{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":29,"countryCode":30,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"RECRUITING","Maastricht","Limburg","6228 HX",{"type":32,"coordinates":43},[44,45],5.68889,50.84833,{"lat":45,"lon":44},[48],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},{"facility":50,"status":25,"city":51,"state":52,"zip":53,"country":29,"countryCode":30,"cosmosGeoPoint":54,"geoPoint":58,"contacts":10},"Maxima Medical Center","Veldhoven","North Brabant","5504 DB",{"type":32,"coordinates":55},[56,57],5.40278,51.41833,{"lat":57,"lon":56},{"facility":60,"status":25,"city":61,"state":62,"zip":63,"country":29,"countryCode":30,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Amsterdam University Medical Center","Amsterdam","North Holland","1105 AZ",{"type":32,"coordinates":65},[66,67],4.88969,52.37403,{"lat":67,"lon":66},{"facility":70,"status":25,"city":71,"state":72,"zip":73,"country":29,"countryCode":30,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"University Medical Center Groningen","Groningen","Provincie Groningen","971 GZ",{"type":32,"coordinates":75},[76,77],6.56667,53.21917,{"lat":77,"lon":76},{"facility":80,"status":25,"city":81,"state":82,"zip":83,"country":29,"countryCode":30,"cosmosGeoPoint":84,"geoPoint":88,"contacts":10},"Leiden University Medical Center","Leiden","South Holland","2333 ZA",{"type":32,"coordinates":85},[86,87],4.49306,52.15833,{"lat":87,"lon":86},{"facility":90,"status":25,"city":91,"state":82,"zip":92,"country":29,"countryCode":30,"cosmosGeoPoint":93,"geoPoint":97,"contacts":10},"Erasmus Medisch Centrum","Rotterdam","3015 GD",{"type":32,"coordinates":94},[95,96],4.47917,51.9225,{"lat":96,"lon":95},{"facility":99,"status":25,"city":100,"state":100,"zip":101,"country":29,"countryCode":30,"cosmosGeoPoint":102,"geoPoint":106,"contacts":10},"University Medical Center Utrecht","Utrecht","3584 CX",{"type":32,"coordinates":103},[104,105],5.12222,52.09083,{"lat":105,"lon":104},{"type":108,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[110],{"name":111,"class":6},"Sanquin Research & Blood Bank Divisions","100627863","bleeding-disorder-of-unknown-cause-in-the-netherlands-100627863",false,"NCT07454161","Bleeding Disorder of Unknown Cause in the Netherlands","Bleeding Disorder of Unknown Cause In the Netherlands (BDUC-iN Study)","BDUC-iN","Inclusion Criteria:\n\n* Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.\n* Increased bleeding tendency based on: Abnormal International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) score (≥ 5 in women age 18-30; ≥ 6 in women age 31-51, ≥ 7 in women age 52 or older; ≥4 in men and ≥ 3 in children) OR Clinical gestalt according to the investigating physician\n* Absence of diagnostic test results for a bleeding disorder in standard laboratory hemostasis tests:\n* Complete blood count: Hemoglobin \\> 6.0 mmol\u002FL; thrombocyte count \\> 100 x10\\^9\u002FL\n* Prothrombin (PT) and activated Partial Thromboplastin Time (aPTT): within local reference range, or prolonged without explanatory factor deficiency\n* Fibrinogen activity, von Willebrand Factor (VWF) antigen \\& activity, Factor VIII, IX, XI and XIII: within local reference range or abnormal but not explaining bleeding phenotype\n* Light transmission aggregometry (LTA): Not diagnostic for a platelet function\n* Kidney function: eGFR \\> 45 ml\u002Fmin\n* Liver function: ALAT, bilirubin \\\u003C 3 x upper limit of normal\n\nExclusion Criteria:\n\n* Use of medication interfering with laboratory hemostasis tests which cannot be stopped before blood withdrawal\n* Pregnancy or lactation at moment of inclusion\n* Presence of an established bleeding disorder\n* Presence of an acquired cause or another explanation for the increased bleeding tendency\n* Inability to provide informed consent","ALL","12 Years",{"count":123,"type":124},500,"ESTIMATED","10 Years","OBSERVATIONAL","The purpose of the Bleeding Disorder of Unknown Cause in the Netherlands study (BDUC-iN) is to learn more about unexplained bleeding in individuals with a bleeding disorder of unknown cause (BDUC). The study aims to better understand why these individuals have increased bleeding and how it affects their health and daily life.\n\nThe main questions of this study are:\n\n1. What are the mechanisms underlying the bleeding tendency in BDUC?\n2. How do bleeding symptoms affect patients' daily functioning and overall health-related quality of life?\n3. How is care delivered to individuals with BDUC, and how can this be improved?\n\nParticipants with increased bleeding tendency who remain undiagnosed after standard coagulation testing and are consequently classified as having BDUC will be enrolled across the Hemophilia treatment centers in the Netherlands. Participants will undergo blood sampling for advanced hemostasis testing and genetic analysis. In addition, participants will complete validated questionnaires to assess bleeding symptoms and health-related quality of life. Participants will be followed longitudinally to evaluate how bleeding symptoms affect daily activities, medical procedures, and overall health-related quality of life.",[129,9],"Hemorrhagic Disorders",[131,132,133,134,135,136,137],"Bleeding disorder of unknown cause","Hemostasis","Diagnosis","Management","Pathofysiology","Quality of life","Prospective","2026-04-23",{"date":140,"type":141},"2026-04-27","ACTUAL",{"date":143,"type":124},"2026-05-01",{"date":145,"type":124},"2039-03-01",{"name":5,"class":6},8]