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RECRUITING
NCT07418099

External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis

Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

View on ClinicalTrials.gov

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

OTHER

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