Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy
NCT ID: NCT04657120
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
698 participants
INTERVENTIONAL
2019-06-01
2025-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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YEARS algorithm
Patients randomized to this arm will be evaluated according to the YEARS algorithm.
YEARS algorithm
Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, haemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level \<1.0 μg/mL (\<1000ng/mL), and in patients with ≥1 items and a D-dimer level \<0.5 μg/mL (\<500 ng/mL) a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.
CTPA as single test
Patients randomized to this arm will undergo a contrast enhanced CTPA.
CTPA
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.
Interventions
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YEARS algorithm
Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, haemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level \<1.0 μg/mL (\<1000ng/mL), and in patients with ≥1 items and a D-dimer level \<0.5 μg/mL (\<500 ng/mL) a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.
CTPA
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.
Eligibility Criteria
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Inclusion Criteria
* Clinically suspected PE as judged by the treating clinician
* Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy
* Outpatients and hospitalized patients
* Age ≥ 18 years
* Signed and dated informed consent, available for start of the trial procedure
Exclusion Criteria
* Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
* Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
* Contraindication to CTPA
* contrast allergy
Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:
* systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min
* need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg
* Need for cardiopulmonary resuscitation
* Inability to follow-up
* Life expectancy less than 3 months
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital, Antwerp
OTHER
University Hospital, Geneva
OTHER
Reinier de Graaf Groep
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Diakonessenhuis, Utrecht
OTHER
Amphia Hospital
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Tergooi Hospital
OTHER
Radboud University Medical Center
OTHER
Bernhoven Hospital
OTHER
Hôpital Louis Mourier
OTHER
Medisch Spectrum Twente
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Maasstad Hospital
OTHER
Flevo Ziekenhuis, Almere
UNKNOWN
Groene Hart Ziekenhuis
OTHER
University Hospital, Brest
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Erik Klok
pr
Principal Investigators
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Menno Huisman, Pr
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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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
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Flevoziekenhuis
Almere Stad, , 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
Countries
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Other Identifiers
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HYDRA (NL68754.058.19)
Identifier Type: -
Identifier Source: org_study_id