[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coagulation-disorder-blood\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coagulation-disorder-blood":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"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":19,"type":20},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.",[24,25],"Coagulation Disorder, Blood","Prolonged APTT",[27,25,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"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","RECRUITING","2026-04-27",{"date":47,"type":48},"2026-05-01","ACTUAL",{"date":50,"type":48},"2026-01-13",{"date":52,"type":20},"2027-03",{"name":54,"class":55},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",16,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100501214","goal-directed-vs-empirical-tranexamic-acid-administrationin-cardiovascular-surgery-100501214","NCT05806346","Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery","Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration","Inclusion Criteria:\n\n* patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass\n* patients who provide written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* refusal of allogenic blood transfusion\n* taking thrombin\n* history of thromboembolic and familial hypercoagulability disease\n* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)\n* hypersensitive to TXA\n* histroy of convulsion or epilepsy\n* taking hemodialysis\n* history of Heparin-induced thrombocytopenia","19 Years",{"count":66,"type":20},764,"INTERVENTIONAL",[69],"NA","The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.\n\nThe study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.\n\nThe secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.\n\nResearchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.",[72,73,74,24,75],"Heart Diseases","Vascular Diseases","Transfusion Related Complication","Fibrinolysis; Hemorrhage","2024-12-15",{"date":78,"type":48},"2024-12-18",{"date":80,"type":48},"2023-08-01",{"date":82,"type":20},"2025-06-30",{"name":84,"class":55},"Konkuk University Medical Center",3]