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

Study acronym: APTTO-EXT
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study description expanded, about 124 wordsv7
  2. Minor Site details revised at 4 of 16 sitesv6
  3. Minor Secondary endpoints: 8 to 9
    • Site details revised at 6 of 16 sites
    v5
  4. Minor Secondary endpoints: 7 to 8v4
  5. Minor Study description expanded, about 12 wordsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 15 to 16
    • Start date changed from estimate of Feb 2026 to Jan 13, 2026
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07418099
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions
(from sponsor)
Coagulation Disorder, Blood, Prolonged APTT
Related terms Blood Coagulation Disorders, Hemostatic Disorders, von Willebrand Diseases
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov