Cancer, Cardiovascular Diseases, Diagnosis, Embolism, Embolism and Thrombosis, Lung Diseases, Pulmonary Embolism, Respiratory Tract Diseases, Vascular Diseases
Conditions
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.
Detailed 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.
Interventions
PROCEDUREYEARS algorithm
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.
PROCEDURECTPA
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.
Sponsors
Insel Gruppe AG, University Hospital Bern
University Hospital, Antwerp
University Hospital, Geneva
Reinier de Graaf Groep
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Diakonessenhuis, Utrecht
Amphia Hospital
Centre Hospitalier Universitaire Vaudois
Hospital Universitario Ramon y Cajal
Tergooi Hospital
Radboud University Medical Center
Bernhoven Hospital
Hôpital Louis Mourier
Medisch Spectrum Twente
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Maasstad Hospital
Flevo Ziekenhuis, Almere
Groene Hart Ziekenhuis
University Hospital, Brest
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent PE | 3 months | Recurrent PE will be observed |
| Deep vein thrombosis (DVT) | 3 months | Number of DVT will be observed |
| Mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| CTPA | 3 months | Number of performed CTPA will be observed in the YEARS-group at baseline |
Countries
Belgium, France, Italy, Netherlands, Spain, Switzerland
Outcome results
None listed