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
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
1,500 participants
Jan 13, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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)
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NCT07418099