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
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerpen University Hospital (UZA) Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Cliniques Universitaires Saint-Luc (CUSL) Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Centre Hospitalier Universitaire de Liège (CHU Liège) Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| The Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux Universitaires de Genève (HUG) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Chu Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hôpital Louis Mourier - APHP Coordinator of this site? Confirm its status | Colombes | France | Unknown status |
| HEGP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Flevoziekenhuis Coordinator of this site? Confirm its status | Almere Stad | Netherlands | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Rijnstate Ziekenhuis Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Reinier de Graaf Gasthuis Coordinator of this site? Confirm its status | Delft | Netherlands | Unknown status |
| Groene Hart Ziekenhuis Coordinator of this site? Confirm its status | Gouda | Netherlands | Unknown status |
| Tergooi MC Coordinator of this site? Confirm its status | Hilversum | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Maasstad Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
| Haaglanden Medisch Centrum Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Bernhoven Ziekenhuis Coordinator of this site? Confirm its status | Uden | Netherlands | Unknown status |
| Diakonessenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.