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NCT04657120Completed

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

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

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
698 (actual)
First submitted
1 Dec 2020
Start date
1 Jun 2019
Primary completion date
23 Aug 2025
Lead sponsor
Leiden University Medical Center
NCT number
NCT04657120

What you commit to

  • Study type: Interventional
  • Participants enrolled: 698
  • From 1 Jun 2019 to the primary completion date, 23 Aug 2025
  • 28 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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:

Other illness

  • 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
  • systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Antwerpen University Hospital (UZA)
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AntwerpBelgiumUnknown status
Cliniques Universitaires Saint-Luc (CUSL)
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BrusselsBelgiumUnknown status
Centre Hospitalier Universitaire de Liège (CHU Liège)
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LiègeBelgiumUnknown status
The Inselspital Bern
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BernSwitzerlandUnknown status
Hôpitaux Universitaires de Genève (HUG)
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GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Chu Brest
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BrestFranceUnknown status
CHU Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
Hôpital Louis Mourier - APHP
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ColombesFranceUnknown status
HEGP
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ParisFranceUnknown status
CHU Saint-Etienne
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Saint-EtienneFranceUnknown status
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
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MilanItalyUnknown status
Fondazione Policlinico Universitario A. Gemelli IRCCS
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RomaItalyUnknown status
Flevoziekenhuis
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Almere StadNetherlandsUnknown status
Amsterdam UMC
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AmsterdamNetherlandsUnknown status
Rijnstate Ziekenhuis
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ArnhemNetherlandsUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
Reinier de Graaf Gasthuis
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DelftNetherlandsUnknown status
Groene Hart Ziekenhuis
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GoudaNetherlandsUnknown status
Tergooi MC
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HilversumNetherlandsUnknown status
Leiden University Medical Center
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LeidenNetherlandsUnknown status
Radboud UMC
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NijmegenNetherlandsUnknown status
Maasstad Ziekenhuis
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RotterdamNetherlandsUnknown status
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsUnknown status
Haaglanden Medisch Centrum
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The HagueNetherlandsUnknown status
Bernhoven Ziekenhuis
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UdenNetherlandsUnknown status
Diakonessenhuis
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UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.