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Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study
The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.
Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Antwerpen University Hospital (UZA)
Antwerp, Belgium
Cliniques Universitaires Saint-Luc (CUSL)
Brussels, Belgium
Centre Hospitalier Universitaire de Liège (CHU Liège)
Liège, Belgium
CHU Brest
Brest, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Louis Mourier - APHP
Colombes, France
HEGP
Paris, France
CHU Saint-Etienne
Saint-Etienne, France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
Milan, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Start Date
June 1, 2019
Primary Completion Date
August 23, 2025
Completion Date
August 23, 2025
Last Updated
December 23, 2025
698
ACTUAL participants
YEARS algorithm
PROCEDURE
CTPA
PROCEDURE
Lead Sponsor
Leiden University Medical Center
Collaborators
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06189313