External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis
Recruiting · NCT07418099 · Observational (researchers observe without assigning treatment) · Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- Availability of clot waveform analysis (CWA) data obtained during routine APTT testing using:
- Optical coagulation analyzers (ACL TOP platform).
- Silica-based APTT reagent (SynthASil®).
- Completion of the standard laboratory evaluation for prolonged APTT as part of routine clinical care, when clinically indicated.
- Samples collected and processed in accordance with the standardized preanalytical protocol defined in the study SOP.
- Patients evaluated in either:
- Preoperative assessment, or
- Routine clinical practice (non-preoperative setting).
Exclusion criteria
- Prolonged prothrombin time (PT) or combined prolongation of PT and APTT.
- 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.
- \. Absence of required CWA data or unavailable clot waveform images.
- \. Samples in which APTT values are outside the measurable range of the analyzer, preventing extraction of CWA-derived parameters.
- Patients with missing essential clinical or laboratory data required for application of the APTTO models.
Where it is running
16 locations listed.
- 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
- Hospital Universitario Severo Ochoa - Leganés, Madrid, Spain