Clinical trial NCT04657120: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cancer
Diagnosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Antwerp
First posted: 2020-12-08
Enrollment: 1566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent PE
timeFrame: 3 months
measure: Deep vein thrombosis (DVT)
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Secondary outcomes:
measure: CTPA
timeFrame: 3 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Antwerpen University Hospital (UZA)
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc (CUSL)
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège (CHU Liège)
city: Brest
country: France
facility: CHU Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Colombes
country: France
facility: Hôpital Louis Mourier - APHP
city: Paris
country: France
facility: HEGP
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Milan
country: Italy
facility: Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi MC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: The Hague
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Uden
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Bern
country: Switzerland
facility: The Inselspital Bern
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
Study officials:
affiliation: Leiden University Medical Center
name: Emily MARTENS, MD
role: PRINCIPAL_INVESTIGATOR
References: