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External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Summary
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. The 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. This 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.
Official title: Multicenter External Validation of the APTTO Predictive Model Based on Clot Waveform Analysis for the Assessment of Prolonged Activated Partial Thromboplastin Time
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2026-01-13
Completion Date
2027-03
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
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.
Locations (16)
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Arnau De Vilanova
Lleida, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Complexo Hospitalario Universitario De Vigo
Vigo, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain