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Brief Title: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy
Official Title: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study
Study ID: NCT04657120
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Antwerpen University Hospital (UZA), Antwerpen, , Belgium
Cliniques Universitaires Saint-Luc (CUSL), Bruxelles, , 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-Étienne, , France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda, Milan, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, , Italy
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, , Netherlands
Flevoziekenhuis, Almere, , Netherlands
Amsterdam UMC, Amsterdam, , Netherlands
Rijnstate Ziekenhuis, Arnhem, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Reinier de Graaf Gasthuis, Delft, , Netherlands
Groene Hart Ziekenhuis, Gouda, , Netherlands
Tergooi MC, Hilversum, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Radboud UMC, Nijmegen, , Netherlands
Maasstad Ziekenhuis, Rotterdam, , Netherlands
Haaglanden Medisch Centrum, The Hague, , Netherlands
Bernhoven Ziekenhuis, Uden, , Netherlands
Diakonessenhuis, Utrecht, , Netherlands
Hospital Universitario Ramón y Cajal, Madrid, , Spain
The Inselspital Bern, Bern, , Switzerland
Hôpitaux Universitaires de Genève (HUG), Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, , Switzerland
Name: Emily MARTENS, MD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR