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

Completed

Conditions studied: Unsuspected Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT01727427

Run by

G. d'Annunzio University

People needed

695

Starts

2012-11-01

Expected to finish

2017-12-01

Last updated by the study team

2019-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• cancer patients with a first diagnosis of unsuspected PE

You may not qualify if…

• 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.

Where it is running

• D.C. Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States
• Clinical Division of Haematology, Department of Medicine I — Vienna, Austria
• Division of Hematology, University of Ottawa — Ottawa, Canada
• CHU Amiens Picardie — Amiens, France
• Arras/Onco Nord Pas de Callais, Loos — Arras, France
• Hopital Saint André — Bordeaux, France
• Brest HIA Clermont Tonnerre — Brest, France
• University hospital Centra La Cavale Blanche — Brest, France
• Montpellier et clinique du parc a Castelnau le nez — Castelnau, France
• Hopital G. Montpied Clermont-Ferrand — Clermont, France
• AP-HP Hopital Louis Mourier — Colombes, France
• Laboratoire d'Hématologie, Dijon — Dijon, France
• CHU de Limoges — Limoges, France
• Centre Hospitalier Lyon-Sud — Lyon, France
• Hopital Europeen Georges Pompidou — Paris, France
• Hopital Loriboisière — Paris, France
• Hospital Pitie Salpetriere — Paris, France
• Service de médecine et Thérapeutique — Saint-Etienne, France
• Division of Vascular Medicine, Department of Medicine, Technical University Dresden — Dresden, Germany
• Ospedali Riuniti — Bergamo, Italy
• Universita degli Studi G. d'Annunzio Chieti e Pescara — Chieti, Italy
• Malattie Cardiovascolari e Nefrourologiche — Palermo, Italy
• Fondazione IRCCS — Pavia, Italy
• Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN) — Reggio Emilia, Italy
• Università dell'Insubria — Varese, Italy

Full record on ClinicalTrials.gov

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