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

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism; Embolism and Thrombosis; Respiratory Tract Diseases; Lung Diseases; Embolism; Vascular Diseases; Cardiovascular Diseases; Cancer; Diagnosis
• Interventions: Procedure: YEARS algorithm; Procedure: CTPA

• Registration Number: NCT04657120
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-28
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1566

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YEARS algorithm	YEARS algorithm	Patients randomized to this arm will be evaluated according to the YEARS algorithm.
CTPA as single test	CTPA	Patients randomized to this arm will undergo a contrast enhanced CTPA.

Primary Outcome Measures

Name	Time	Method
Recurrent PE	3 months	Recurrent PE will be observed
Mortality	3 months	The mortality will be observed
Deep vein thrombosis (DVT)	3 months	Number of DVT will be observed

Secondary Outcome Measures

Name	Time	Method
CTPA	3 months	Number of performed CTPA will be observed in the YEARS-group at baseline

Trial Locations

Locations (28)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Radboud UMC; 🇳🇱 Nijmegen, Netherlands

HEGP; 🇫🇷 Paris, France

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda; 🇮🇹 Milan, Italy

Hôpital Louis Mourier - APHP; 🇫🇷 Colombes, France

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands

Flevoziekenhuis; 🇳🇱 Almere, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Tergooi MC; 🇳🇱 Hilversum, Netherlands

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy

Bernhoven Ziekenhuis; 🇳🇱 Uden, Netherlands

Haaglanden Medisch Centrum; 🇳🇱 The Hague, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Hôpitaux Universitaires de Genève (HUG); 🇨🇭 Geneva, Switzerland

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Cliniques Universitaires Saint-Luc (CUSL); 🇧🇪 Bruxelles, Belgium

Antwerpen University Hospital (UZA); 🇧🇪 Antwerpen, Belgium

Centre Hospitalier Universitaire de Liège (CHU Liège); 🇧🇪 Liège, Belgium

CHU Brest; 🇫🇷 Brest, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

The Inselspital Bern; 🇨🇭 Bern, Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Switzerland