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

NCT04657120 | Completed

• 1 other identifier: HYDRA (NL68754.058.19)
• Study Type: interventional
• Target: 698
• Locations: 6 countries
• Sites: 28

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.

Conditions

Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Cancer; Diagnosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (3)

• Recurrent PE

  Recurrent PE will be observed

  3 months

• Deep vein thrombosis (DVT)

  Number of DVT will be observed

  3 months

• 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

  3 months

Secondary Outcomes (1)

• CTPA

  3 months

Study Arms (2)

YEARS algorithm

EXPERIMENTAL

Patients randomized to this arm will be evaluated according to the YEARS algorithm.

Procedure: YEARS algorithm

CTPA as single test

ACTIVE COMPARATOR

Patients randomized to this arm will undergo a contrast enhanced CTPA.

Procedure: CTPA

Interventions

YEARS algorithm PROCEDURE

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.

YEARS algorithm

CTPA PROCEDURE

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

CTPA as single test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Outpatients and hospitalized patients
• Age ≥ 18 years
• Signed and dated informed consent, available for start of the trial procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• University Hospital, Antwerp: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• Reinier de Graaf Groep: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Diakonessenhuis, Utrecht: collaborator
• Amphia Hospital: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Tergooi Hospital: collaborator
• Radboud University Medical Center: collaborator
• Bernhoven Hospital: collaborator
• Hôpital Louis Mourier: collaborator
• Medisch Spectrum Twente: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Maasstad Hospital: collaborator
• Flevo Ziekenhuis, Almere: collaborator
• Groene Hart Ziekenhuis: collaborator
• University Hospital, Brest: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (28)

Antwerpen University Hospital (UZA)

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc (CUSL)

Brussels, Belgium

Location

Centre Hospitalier Universitaire de Liège (CHU Liège)

Liège, Belgium

Location

CHU Brest

Brest, 29609, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Louis Mourier - APHP

Colombes, 92700, France

Location

HEGP

Paris, 75015, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

Milan, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Tergooi MC

Hilversum, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

Bernhoven Ziekenhuis

Uden, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

The Inselspital Bern

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Neoplasms; Disease

Interventions

4-((1,4,8,11-tetraazacyclotetradec-1-yl)methyl)benzoic acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Menno Huisman, Pr

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pr

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: June 1, 2019
• Primary Completion: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by an internal committee . Requestors will be required to sign and complete a data access agreement.

Locations

NL (14); CH (3); BE (3); IT (2); ES (1); FR (5)