Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy (HYDRA)

December 16, 2025 updated by: Erik Klok, Leiden University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
698

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Antwerpen University Hospital (UZA)
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc (CUSL)
      • Liège, Belgium
        • Centre Hospitalier Universitaire de Liège (CHU Liège)
  • France
      • Brest, France, 29609
        • CHU Brest
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Colombes, France, 92700
        • Hôpital Louis Mourier - APHP
      • Paris, France, 75015
        • HEGP
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne
  • Italy
      • Milan, Italy
        • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
      • Roma, Italy
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Jeroen Bosch ziekenhuis
      • Almere Stad, Netherlands
        • Flevoziekenhuis
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Gouda, Netherlands
        • Groene Hart ziekenhuis
      • Hilversum, Netherlands
        • Tergooi Mc
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Nijmegen, Netherlands
        • Radboud UMC
      • Rotterdam, Netherlands
        • Maasstad ziekenhuis
      • The Hague, Netherlands
        • Haaglanden Medisch Centrum
      • Uden, Netherlands
        • Bernhoven Ziekenhuis
      • Utrecht, Netherlands
        • Diakonessenhuis
  • Spain
      • Madrid, Spain
        • Hospital Universitario Ramon Y Cajal
  • Switzerland
      • Bern, Switzerland
        • The Inselspital Bern
      • Geneva, Switzerland
        • Hopitaux Universitaires de Geneve (HUG)
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following 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:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YEARS algorithm
Patients randomized to this arm will be evaluated according to the YEARS algorithm.
Procedure: 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.
Active Comparator: CTPA as single test
Patients randomized to this arm will undergo a contrast enhanced CTPA.
Procedure: CTPA
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrent PE
Time Frame: 3 months
Recurrent PE will be observed
3 months
Deep vein thrombosis (DVT)
Time Frame: 3 months
Number of DVT will be observed
3 months
Mortality
Time Frame: 3 months
The mortality will be observed Adjudicated according to ISTH definition in which both PE-related death as well as unexplained death will count towards primary outcome
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CTPA
Time Frame: 3 months
Number of performed CTPA will be observed in the YEARS-group at baseline
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radboud University Medical Center
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
University Hospital, Brest
University Hospital, Antwerp
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Hospital Universitario Ramon y Cajal
Maasstad Hospital
Diakonessenhuis, Utrecht
Groene Hart Ziekenhuis
Reinier de Graaf Groep
Bernhoven Hospital
Medisch Spectrum Twente
Hôpital Louis Mourier
Amphia Hospital
Tergooi Hospital
Flevo Ziekenhuis, Almere
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Menno Huisman, Pr, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HYDRA (NL68754.058.19)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by an internal committee . Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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