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Study identifier: NCT07418099 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Coagulation Disorder, Blood · Prolonged APTT  ·  Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

PhaseN/A
Planned participants1500
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Diego Velasco Rodríguez, MD, PhD  ·  +34 669 98 04 32  ·  diego.velascor@quironsalud.es

Always discuss trial participation with your own doctor first.

Locations (16)

Hospital Universitario Severo OchoaLeganés, Madrid, SpainRecruiting
Hospital de la Santa Creu i Sant PauBarcelona, SpainRecruiting
Hospital Universitario Arnau De VilanovaLleida, SpainRecruiting
Hospital Universitario 12 de OctubreMadrid, SpainRecruiting
Hospital Universitario Clínico San CarlosMadrid, SpainNot Yet Recruiting
Hospital Universitario Fundación Jiménez DíazMadrid, SpainRecruiting
Hospital Universitario Gregorio MarañónMadrid, SpainNot Yet Recruiting
Hospital Universitario Puerta de HierroMadrid, SpainNot Yet Recruiting
Hospital Universitario Ramón y CajalMadrid, SpainRecruiting
Hospital Clínico Universitario Virgen de la ArrixacaMurcia, SpainNot Yet Recruiting
Clínica Universidad de NavarraPamplona, SpainNot Yet Recruiting
Hospital Clínico Universitario de SalamancaSalamanca, SpainNot Yet Recruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07418099