[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625089":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":229,"collaborators":10,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":10,"maxAge":10,"enrollmentInfo":241,"targetDuration":10,"studyType":244,"phases":10,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with prolonged activated partial thromboplastin time (APTT)",null,"Patients with prolonged activated partial thromboplastin time (APTT) and normal prothrombin time undergoing routine laboratory evaluation. Clot waveform analysis (CWA) data and clinical information are collected prospectively as part of standard care and analyzed using the APTTO predictive models. No additional diagnostic or therapeutic procedures are performed.",[13],"Other: Clot waveform analysis-based risk stratification (APTTO models)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Clot waveform analysis-based risk stratification (APTTO models)","Application of the APTTO predictive models (APTTO1 and APTTO2) to clot waveform analysis parameters generated during routine activated partial thromboplastin time testing, for research purposes only. The model output does not influence clinical management or surgical decision-making during the study.",[9],[20],{"name":21,"affiliation":22,"role":23},"Diego Velasco Rodríguez, MD, PhD","Hospital Universitario Fundación Jiménez Díaz \u002F IIS-FJD","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+34 669 98 04 32","diego.velascor@quironsalud.es",[30,48,61,74,86,97,108,118,128,138,151,164,177,190,203,216],{"facility":31,"status":32,"city":33,"state":34,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hospital Universitario Severo Ochoa","RECRUITING","Leganés","Madrid","Spain","ES",{"type":38,"coordinates":39},"Point",[40,41],-3.7635,40.32718,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":10,"email":47},"Ramón Rodríguez Rodríguez, MD","+34 91 481 80 00","ramon.rodriguez@salud.madrid.org",{"facility":49,"status":32,"city":50,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Hospital de la Santa Creu i Sant Pau","Barcelona",{"type":38,"coordinates":52},[53,54],2.15899,41.38879,{"lat":54,"lon":53},[57],{"name":58,"role":26,"phone":59,"phoneExt":10,"email":60},"Noèlia Vilalta Seto, MD, PhD","+34 932 91 90 00","nvilalta@santpau.cat",{"facility":62,"status":32,"city":63,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hospital Universitario Arnau De Vilanova","Lleida",{"type":38,"coordinates":65},[66,67],0.62218,41.61674,{"lat":67,"lon":66},[70],{"name":71,"role":26,"phone":72,"phoneExt":10,"email":73},"Albert Tugués Peiró, MD","+34 973 24 81 00","atugues.lleida.ics@gencat.cat",{"facility":75,"status":32,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hospital Universitario 12 de Octubre",{"type":38,"coordinates":77},[78,79],-3.70256,40.4165,{"lat":79,"lon":78},[82],{"name":83,"role":26,"phone":84,"phoneExt":10,"email":85},"Nerea Castro Quismondo, MD","+34 913 90 80 00","nerecq@hotmail.com",{"facility":87,"status":88,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Hospital Universitario Clínico San Carlos","NOT_YET_RECRUITING",{"type":38,"coordinates":90},[78,79],{"lat":79,"lon":78},[93],{"name":94,"role":26,"phone":95,"phoneExt":10,"email":96},"Cristina García Sánchez, MD","+34 913 30 30 00","cgarciasanchez@salud.madrid.org",{"facility":98,"status":32,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Hospital Universitario Fundación Jiménez Díaz",{"type":38,"coordinates":100},[78,79],{"lat":79,"lon":78},[103,105],{"name":21,"role":26,"phone":10,"phoneExt":10,"email":104},"diegovelascorodriguez@gmail.com",{"name":106,"role":26,"phone":10,"phoneExt":10,"email":107},"Nuria Revilla, MD, PhD","nuria.revilla@quironsalud.es",{"facility":109,"status":88,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Hospital Universitario Gregorio Marañón",{"type":38,"coordinates":111},[78,79],{"lat":79,"lon":78},[114],{"name":115,"role":26,"phone":116,"phoneExt":10,"email":117},"Cristina Pascual Izquierdo, MD, PhD","+34 91 586 80 00","crisizquierdo3@yahoo.es",{"facility":119,"status":88,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Hospital Universitario Puerta de Hierro",{"type":38,"coordinates":121},[78,79],{"lat":79,"lon":78},[124],{"name":125,"role":26,"phone":126,"phoneExt":10,"email":127},"Cristina Fernández Maqueda, MD","+34 91 191 60 00","Cristinat.maqueda@gmail.com",{"facility":129,"status":32,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Hospital Universitario Ramón y Cajal",{"type":38,"coordinates":131},[78,79],{"lat":79,"lon":78},[134],{"name":135,"role":26,"phone":136,"phoneExt":10,"email":137},"Pilar Massó Asensio, MD","+34 91 336 80 00","pmasso@salud.madrid.org",{"facility":139,"status":88,"city":140,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hospital Clínico Universitario Virgen de la Arrixaca","Murcia",{"type":38,"coordinates":142},[143,144],-1.13004,37.98704,{"lat":144,"lon":143},[147],{"name":148,"role":26,"phone":149,"phoneExt":10,"email":150},"Vanessa Roldán Schilling, MD, PhD","+34 968 369 500","vroldans@um.es",{"facility":152,"status":88,"city":153,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Clínica Universidad de Navarra","Pamplona",{"type":38,"coordinates":155},[156,157],-1.64323,42.81687,{"lat":157,"lon":156},[160],{"name":161,"role":26,"phone":162,"phoneExt":10,"email":163},"María Marcos Jubilar, MD, PhD","+34 948 25 54 00","mmarcos.3@unav.es",{"facility":165,"status":88,"city":166,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Hospital Clínico Universitario de Salamanca","Salamanca",{"type":38,"coordinates":168},[169,170],-3.67975,40.42972,{"lat":170,"lon":169},[173],{"name":174,"role":26,"phone":175,"phoneExt":10,"email":176},"José Ramón González Porras, MD, PhD","+34 923 29 11 00","jrgp@usal.es",{"facility":178,"status":88,"city":179,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Complexo Hospitalario Universitario de Santiago","Santiago de Compostela",{"type":38,"coordinates":181},[182,183],-8.54569,42.88052,{"lat":183,"lon":182},[186],{"name":187,"role":26,"phone":188,"phoneExt":10,"email":189},"Matilde Rodríguez Ruiz, MD","+34 981 95 10 00","matilde.rodriguez.ruiz@sergas.es",{"facility":191,"status":32,"city":192,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Hospital Clínico Universitario de Valladolid","Valladolid",{"type":38,"coordinates":194},[195,196],-4.72353,41.65541,{"lat":196,"lon":195},[199],{"name":200,"role":26,"phone":201,"phoneExt":10,"email":202},"Carolina Bombín Canal, MD","+34 983 42 00 00","cbombin@saludcastillayleon.es",{"facility":204,"status":88,"city":205,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Complexo Hospitalario Universitario De Vigo","Vigo",{"type":38,"coordinates":207},[208,209],-8.72264,42.23282,{"lat":209,"lon":208},[212],{"name":213,"role":26,"phone":214,"phoneExt":10,"email":215},"María Elsa López Ansoar, MD","+34 986 51 47 51","elsa.lopez.ansoar@sergas.es",{"facility":217,"status":88,"city":218,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Hospital Clínico Universitario Lozano Blesa","Zaragoza",{"type":38,"coordinates":220},[221,222],-0.87734,41.65606,{"lat":222,"lon":221},[225],{"name":226,"role":26,"phone":227,"phoneExt":10,"email":228},"Olga Gavín Sebastián, MD, PhD","+34 976 76 57 00","ogavin@salud.aragon.es",{"type":23,"investigatorFullName":230,"investigatorTitle":231,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Diego Velasco Rodríguez","Principal Investigator","100625089","external-multicenter-validation-of-the-aptto-model-for-prolonged-aptt-using-clot-waveform-analysis-100625089",false,"NCT07418099","External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis","Multicenter External Validation of the APTTO Predictive Model Based on Clot Waveform Analysis for the Assessment of Prolonged Activated Partial Thromboplastin Time","APTTO-EXT","Inclusion Criteria:\n\n1. Patients of any age (pediatric and adult populations) undergoing coagulation testing with:\n\n   \\- Prolonged activated partial thromboplastin time (APTT), defined as an APTT ratio ≥ 1.25.\n\n   \\- Normal prothrombin time (PT), according to local laboratory reference ranges.\n2. Availability of clot waveform analysis (CWA) data obtained during routine APTT testing using:\n\n   * Optical coagulation analyzers (ACL TOP platform).\n   * Silica-based APTT reagent (SynthASil®).\n3. Completion of the standard laboratory evaluation for prolonged APTT as part of routine clinical care, when clinically indicated.\n4. Samples collected and processed in accordance with the standardized preanalytical protocol defined in the study SOP.\n5. Patients evaluated in either:\n\n   * Preoperative assessment, or\n   * Routine clinical practice (non-preoperative setting).\n\nExclusion Criteria:\n\n1. Prolonged prothrombin time (PT) or combined prolongation of PT and APTT.\n\n2- Inadequate preanalytical conditions, defined as non-compliance with the study SOP, including but not limited to:\n\n* Incorrect blood-to-anticoagulant ratio.\n* Delayed plasma processing beyond protocol-defined time limits.\n* Inadequate centrifugation or plasma quality.\n\n  3\\. Absence of required CWA data or unavailable clot waveform images.\n\n  4\\. Samples in which APTT values are outside the measurable range of the analyzer, preventing extraction of CWA-derived parameters.\n\n  5- Patients with missing essential clinical or laboratory data required for application of the APTTO models.","ALL",{"count":242,"type":243},1500,"ESTIMATED","OBSERVATIONAL","Prolonged activated partial thromboplastin time (APTT) is a frequent laboratory finding that may reflect a broad spectrum of underlying conditions, ranging from benign laboratory abnormalities to clinically relevant hemostatic disorders. Clot waveform analysis (CWA), automatically generated during routine APTT testing by optical coagulation analyzers, provides additional quantitative and qualitative information on clot formation dynamics.\n\nThe APTTO model is a previously developed two-step predictive algorithm based on CWA features designed to estimate the probability of a pathological cause of prolonged APTT and to differentiate lupus anticoagulant from intrinsic pathway factor deficiency or von Willebrand disease. Internal validation has demonstrated good discrimination and calibration.\n\nThis multicenter observational study aims to perform an external validation of the APTTO model in independent patient cohorts, assessing its discrimination, calibration, and decision-analytic performance without model updating.",[247,248],"Coagulation Disorder, Blood","Prolonged APTT",[250,248,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266],"Activated Partial Thromboplastin Time","Clot Waveform Analysis","CWA","Preoperative Assessment","Predictive Model","Diagnostic Algorithm","Risk Stratification","Decision Support Systems","Hemostasis","Coagulation Disorders","Lupus Anticoagulant","Coagulation Factor Deficiency","von Willebrand Disease","Laboratory Automation","Clinical Decision-Making","Surgical Delay","Resource Utilization","2026-04-27",{"date":269,"type":270},"2026-05-01","ACTUAL",{"date":272,"type":270},"2026-01-13",{"date":274,"type":243},"2027-03",{"name":5,"class":6},16]