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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
698
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.
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.
Antwerpen University Hospital (UZA)
Antwerp, Belgium
Cliniques Universitaires Saint-Luc (CUSL)
Brussels, Belgium
Centre Hospitalier Universitaire de Liège (CHU Liège)
Liège, Belgium
CHU Brest
Brest, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Louis Mourier - APHP
Colombes, France
HEGP
Paris, France
CHU Saint-Etienne
Saint-Etienne, France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
Milan, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
...and 18 more locations
Recurrent PE
Recurrent PE will be observed
Time frame: 3 months
Deep vein thrombosis (DVT)
Number of DVT will be observed
Time frame: 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
Time frame: 3 months
CTPA
Number of performed CTPA will be observed in the YEARS-group at baseline
Time frame: 3 months
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