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

G. d'Annunzio University

Status: Completed

Conditions: Unsuspected Pulmonary Embolism

Treatments: Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin

Study type: Observational

Funder types: Other

Identifiers

NCT01727427

215/2012

Details and patient eligibility

About

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.

Enrollment: 695 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cancer patients with a first diagnosis of unsuspected PE

Exclusion criteria

1. age <18 years;
2. ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
3. life expectancy less than 3 months.

Trial design

695 participants in 1 patient group

Anticoagulants, aspirin

Description:

Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration

Treatment:

Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin