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

Recruitingn/aAges any - anyAllInstituto de Investigación Sanitaria de la Fundac…
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients of any age (pediatric and adult populations) undergoing coagulation testing with: \- Prolonged activated partial thromboplastin time (APTT), defined as an APTT ratio ≥ 1.25. \- Normal prothrombin time (PT), according to local laboratory reference ranges. 2. Availability of clot waveform analysis (CWA) data obtained during routine APTT testing using: * Optical coagulation analyzers (ACL TOP platform). * Silica-based APTT reagent (SynthASil®). 3. Completion of the standard laboratory evaluation for prolonged APTT as part of routine clinical care, when clinically indicated. 4. Samples collected and processed in accordance with the standardized preanalytical protocol defined in the study SOP. 5. Patients evaluated in either: * Preoperative assessment, or * Routine clinical practice (non-preoperative setting). Exclusion Criteria: 1. Prolonged prothrombin time (PT) or combined prolongation of PT and APTT. 2- Inadequate preanalytical conditions, defined as non-compliance with the study SOP, including but not limited to: * Incorrect blood-to-anticoagulant ratio. * Delayed plasma processing beyond protocol-defined time limits. * Inadequate centrifugation or plasma quality. 3\. Absence of required CWA data or unavailable clot waveform images. 4\. Samples in which APTT values are outside the measurable range of the analyzer, preventing extraction of CWA-derived parameters. 5- Patients with missing essential clinical or laboratory data required for application of the APTTO models.
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What it tests

  • Clot waveform analysis-based risk stratification (APTTO models)
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Where

16 sites
Hospital Universitario Severo Ochoa
Leganés, 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

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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