An observational study in Unsuspected Pulmonary Embolism, sponsored by G. d'Annunzio University. Completed at 46 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by G. d'Annunzio University · Observational
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 695 is above the median of 392 across 324 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All ambulatory or hospitalized cancer patients with a first diagnosis of unsuspected PE. Both solid and hematological cancers at any stage of disease will be considered for inclusion
Exclusion Criteria:
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
Parenteral or oral anticoagulant Antiplatelet agent
Also known as: Enoxaparin (Clexane), Dalteparin (Fragmin), Nadroparin (Fraxiparin), Tinzaparin (Innohep), Bemiparin (Ivor), Fondaparinux (Arixtra), Warfarin (Coumadin), Acenocoumarol (Sintrom), Phenprocoumon (Marcoumar), Acetylsalicylic acid (Aspirin), Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis)
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
Suspected recurrent PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. 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: 1. abnormal CUS; 2. an intra-luminal filling defect on venography.
Time frame: one year
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.
Time frame: one year
Mortality
Overall mortality
Time frame: one year
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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G. d'Annunzio University