pulmonary embolism clotting in the lung
Conditions
Interventions
Patients will be randomized into management by either YEARS-algorithm or direct
CTPA, on a 1:1 basis and stratified by center.
The randomization process will occur directly after signing informed con
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion 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 randomisation or in the presence of metastases, including recurrent or local metastatic malignancy - Age >= 18 years - Signed and dated informed consent, available for start of the trial procedure
Exclusion criteria
Exclusion criteria: - Symptoms for more than 10 days - 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: o if initiated 24 hours or more prior to eligibility assessment (prophylactic dose with Low Molecular Weight Heparin (LMWH) or direct oral anticoagulants (DOAC) is permitted), or; o if initiation is expected prior to eligibility assessment for different indication (i.e., atrial fibrillation) - Contraindication to CTPA o contrast allergy o impaired kidney function (eGFR 120 beats per minute (unless arrhythmia) or SBP drop by > 40 mm Hg, for > 15 min o need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of > 100 mmHg o need for cardiopulmonary resuscitation - Suggestion of PE on previously performed oncologic CT scan, for which now PE-specific diagnostic testing is only performed as means of verification - Participating in another concurrent study on thromboprophylaxis - Prior participation in the Hydra study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Recurrent venous thromboembolism during three months follow-up in patients with initially normal diagnostic tests. Efficiency: Number of CTPA needed in each randomisation group.An independent adjudication committee consisting of two thrombosis specialists not involved in the study will evaluate all new and recurrent suspected clinical events during the 90-day follow-up period. The events include DVT, PE or death (our primary endpoints), and MB.Documentation required for the adjudication of suspected clinical events will be limited to clinical summaries, imaging reports, and other relevant findings, e.g., laboratory or physical exam. Requests for copies of films or images from objective tests will only be made when deemed necessary. Disagreements will be solved by discussion between the two specialists of the adjudication committee. If necessary, a third thrombosis specialist not involved in the study will be asked to resolve any persisting disagreements. All deaths during follow-up will be adjudicated as to the likelihood that the death was related to PE using the International Society on Thrombosis and Haemostasis (ISTH) definition for PE-related death and classification of the cause of death [22]: A. PE-related death (i.e., certainly / highly probable PE-related)B. undetermined cause of death (i.e., possibly PE-related)C. cause other than PE (i.e., PE-unrelated)* For the main analysis assessing the safety and efficiency of both diagnostic strategies for ruling out PE, both category A (“PE-related death”) and category B (“undetermined cause of death”) will be considered PE-related. Interim analysis: The study team has decided to perform an interim analysis in response to the higher-than anticipated all-cause mortality rate in both study arms. The objective of this interim analysis is to account for the higher-than-anticipated mortality rate, which could be linked to a higher pre | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the occurrence (timing, location and severity) of recurrent symptomatic VTE during follow-up in both study arms in order to better differentiate between missed PE diagnoses and new onset VTE To compare differences in the rate of isolated sub-segmental PE, defined as CTPA demonstrating an intraluminal filling defect in a sub-segmental artery with no filling defect visualized at more proximal artery levels, in both study arms To assess the occurrence of incidental VTE, defined as thromboembolism that was detected by means of imaging tests performed for reasons other than clinical suspicion of venous thromboembolism[18], during follow up in both study arms To evaluate contrast material induced complications (allergic reactions and contrast material induced nephropathy) in both study arms. To evaluate usage and safety of antithrombotic treatment in both study groups To evaluate practice patterns of anticoagulation therapy during end-of-life care in terminally ill patients with cancer. To evaluate quality of life in patients with PE at baseline or follow-up in this study by implementing the Pulmonary Embolism Quality of Life (PEmb-QoL) Questionnaire. To post-hoc evaluate the performance of the 4-Level Pulmonary Embolism Clinical Probability Score (4PEPS), in patients randomized for YEARS within the Hydra study. | — |
Countries
Belgium, France, Italy, Netherlands, Spain, Switzerland
Contacts
Public ContactB Akerboom
Leids Universitair Medisch Centrum
Outcome results
None listed