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

NCT07418099 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Coagulation Disorder, Blood
  • Prolonged APTT

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.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Diego Velasco Rodríguez, MD, PhD · Hospital Universitario Fundación Jiménez Díaz / IIS-FJD

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418099 on ClinicalTrials.gov