Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

Study Overview
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Brief Summary
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The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism. The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.

Official Title
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Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

Conditions
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Unsuspected Pulmonary Embolism

Intervention / Treatment
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* Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cancer patients with a first diagnosis of unsuspected PE Exclusion Criteria: age <18 years; ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE; life expectancy less than 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anticoagulants, aspirin<br>Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration | Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin<br>* Parenteral or oral anticoagulant Antiplatelet agent<br>* Other names: Apixaban (Eliquis);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis | Suspected recurrent PE with one of the following: new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; new perfusion defect of at least 75% on V/Q lung scan; inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: PE based on objective diagnostic testing or autopsy or death not attributed to a documented cause and for which DVT/PE cannot be ruled out. Suspected (recurrent) DVT with one of the following findings: abnormal CUS; an intra-luminal filling defect on venography. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major, clinically relevant non-major bleeding, and minor bleeding | Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death. Other clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life. All other bleeding events will be classified as minor. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unsuspected, pulmonary embolism, cancer