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

Leiden University Medical Center (LUMC)

Status: Completed

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

Treatments: Procedure: YEARS algorithm; Procedure: CTPA

Study type: Interventional

Funder types: Other

Identifiers

NCT04657120

HYDRA (NL68754.058.19)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 698 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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698 participants in 2 patient groups

YEARS algorithm

Experimental group

Description:

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

Treatment:

Procedure: YEARS algorithm

CTPA as single test

Active Comparator group

Description:

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

Treatment:

Procedure: CTPA