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Pulmonary EmbolismHYDRANCT04657120

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

A study testing YEARS algorithm and CTPA in people with Pulmonary Embolism and Embolism, run by Leiden University Medical Center at 28 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YEARS algorithm and CTPA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
698 participants
Where
28 sitesin 6 countries
Study dates
1 Jun 2019to 23 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 11Show fewer
  • 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

Trial locations and contacts

28 sites in 6 countries.

28 sites in 6 countries

Netherlands14 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Flevoziekenhuis

    Almere Stad

  • Amsterdam UMC

    Amsterdam

  • Rijnstate Ziekenhuis

    Arnhem

  • Amphia Ziekenhuis

    Breda

  • Reinier de Graaf Gasthuis

    Delft

  • Groene Hart Ziekenhuis

    Gouda

  • Tergooi MC

    Hilversum

  • Leiden University Medical Center

    Leiden

  • Radboud UMC

    Nijmegen

  • Maasstad Ziekenhuis

    Rotterdam

  • Haaglanden Medisch Centrum

    The Hague

  • Bernhoven Ziekenhuis

    Uden

  • Diakonessenhuis

    Utrecht

Other trials in Netherlands

France5 sites

  • CHU Brest

    Brest, 29609

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Hôpital Louis Mourier - APHP

    Colombes, 92700

  • HEGP

    Paris, 75015

  • CHU Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

Belgium3 sites

  • Antwerpen University Hospital (UZA)

    Antwerp

  • Cliniques Universitaires Saint-Luc (CUSL)

    Brussels

  • Centre Hospitalier Universitaire de Liège (CHU Liège)

    Liège

Other trials in Belgium

Switzerland3 sites

  • The Inselspital Bern

    Bern

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne

Other trials in Switzerland

Italy2 sites

  • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

    Milan

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma

Other trials in Italy

Spain1 site

  • Hospital Universitario Ramón y Cajal

    Madrid

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
YEARS algorithm, CTPA
Medical subject headings
Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YEARS algorithmProcedure or surgery

    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.

  • CTPAProcedure or surgery

    Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

Study groups in NCT04657120
Study groupRoleWhat they receive
YEARS algorithmExperimentalPatients randomized to this arm will be evaluated according to the YEARS algorithm.
Receives: Procedure: YEARS algorithm
CTPA as single testActive comparatorPatients randomized to this arm will undergo a contrast enhanced CTPA.
Receives: Procedure: CTPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent PE

    Recurrent PE will be observed

    Measured: 3 months

  2. Deep vein thrombosis (DVT)

    Number of DVT will be observed

    Measured: 3 months

  3. Mortality

    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

    Measured: 3 months

Secondary outcomes (1)

  1. CTPA

    Number of performed CTPA will be observed in the YEARS-group at baseline

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start1 Jun 2019
  3. Primary completion23 Aug 2025
  4. Study completion23 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657120
Sponsor's protocol ID
HYDRA (NL68754.058.19)
Acronym
HYDRA
Status last verified
Dec 2025
First submitted
1 Dec 2020
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Publications

  • Martens ESL, Akerboom B, Baumgartner C, Brouwer RE, Cavallaro C, Coppens M, Costantino G, Couturaud F, D'Errico A, van Dooren YPA, Gianni F, van der Griend R, Grootenboers MJJH, Hugli O, van der Hulle T, Jaderi Z, Jimenez D, Kamphuisen PW, Lanting VR, Leentjens J, Maas ML, Mahe I, van Meer OA, van Mens TE, Out M, Pola R, Pulver D, Raskin J, Righini M, Sprenger RA, Stals MAM, Talerico R, Tritschler T, Ten Wolde M, Klok FA, Huisman MV; HYDRA study group. Electronic address: research_interne@lumc.nl. A study protocol for a randomised controlled trial evaluating the safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography only for suspected acute pulmonary embolism in patients with cancer: the Hydra Study. Thromb Res. 2026 Jul;263:109745. doi: 10.1016/j.thromres.2026.109745. Epub 2026 Jun 11.

    PubMed 42365759

Questions about this trial

What is this clinical trial studying?

A study testing YEARS algorithm and CTPA in people with Pulmonary Embolism and Embolism, run by Leiden University Medical Center at 28 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Netherlands, France, Belgium, Switzerland, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent PE (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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