Overview
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.
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
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