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

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.

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Key information

Conditions

Unsuspected Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Division of Haematology, Department of Medicine I, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin, fondaparinux, vitamin-K antagonists, aspirin

Drug

Parenteral or oral anticoagulant Antiplatelet agent

Other names: 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)

Primary outcomes

Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis

Time frame: one year
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.

Secondary outcomes

Major, clinically relevant non-major bleeding, and minor bleeding

Time frame: one year

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.

Other outcomes

Mortality

Time frame: one year

Overall mortality

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Nov 16, 2012
Registry last updated: Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed