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NCT Number: NCT04657120

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

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.

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Key information

Conditions

Pulmonary Embolism Cancer Cardiovascular Diseases Diagnosis Disease Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerpen University Hospital (UZA), Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

CTPA

Procedure

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

Primary outcomes

  1. Recurrent PE

    Time frame: 3 months

    Recurrent PE will be observed

  2. Deep vein thrombosis (DVT)

    Time frame: 3 months

    Number of DVT will be observed

  3. Mortality

    Time frame: 3 months

    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

Secondary outcomes

  1. CTPA

    Time frame: 3 months

    Number of performed CTPA will be observed in the YEARS-group at baseline

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HYDRA

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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