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

Completed

• Conditions: Unsuspected Pulmonary Embolism
• Interventions: Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin

• Registration Number: NCT01727427
• Lead Sponsor: G. d'Annunzio University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 695

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis	one year	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.

Secondary Outcome Measures

Name	Time	Method
Major, clinically relevant non-major bleeding, and minor bleeding	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.

Trial Locations

Locations (46)

Hospital Vall D'Hebron; 🇪🇸 Barcelona, Spain

D.C. Veterans Affairs Medical Center; 🇺🇸 Washington, District of Columbia, United States

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Montpellier et clinique du parc a Castelnau le nez; 🇫🇷 Castelnau, France

ICO_Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

Hospital Clinico Benidorm, Alicante; 🇪🇸 Benidorm, Spain

Hospital Universitario Infantia Sofia; 🇪🇸 Madrid, Spain

Service de médecine et Thérapeutique; 🇫🇷 Saint-Etienne, France

Hospital Universitario de Móstoles; 🇪🇸 Madrid, Spain

Clinical Division of Haematology, Department of Medicine I; 🇦🇹 Vienna, Austria

Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

Hospital Pitie Salpetriere; 🇫🇷 Paris, France

CHU Amiens Picardie; 🇫🇷 Amiens, France

Slotervaart hospital; 🇳🇱 Amsterdam, Netherlands

Universita degli Studi G. d'Annunzio Chieti e Pescara; 🇮🇹 Chieti, Italy

Malattie Cardiovascolari e Nefrourologiche; 🇮🇹 Palermo, Italy

Hopital Loriboisière; 🇫🇷 Paris, France

Laboratoire d'Hématologie, Dijon; 🇫🇷 Dijon, France

AP-HP Hopital Louis Mourier; 🇫🇷 Colombes, France

Hopital G. Montpied Clermont-Ferrand; 🇫🇷 Clermont, France

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Hospital Universitario Insular de Gran Canarias; 🇪🇸 Las Palmas, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Santa María Nei; 🇪🇸 Orense, Spain

Hospital Obispo Polanco; 🇪🇸 Teruel, Spain

Hospital Nuestra Sra del Prado Talavera de la Reina; 🇪🇸 Toledo, Spain

Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN); 🇮🇹 Reggio Emilia, Italy

Università dell'Insubria; 🇮🇹 Varese, Italy

Hospital de Sabadell; 🇪🇸 Barcelona, Spain

Hopital Saint André; 🇫🇷 Bordeaux, France

Division of Hematology, University of Ottawa; 🇨🇦 Ottawa, Canada

Arras/Onco Nord Pas de Callais, Loos; 🇫🇷 Arras, France

Brest HIA Clermont Tonnerre; 🇫🇷 Brest, France

University hospital Centra La Cavale Blanche; 🇫🇷 Brest, Cedex, France

CHU de Limoges; 🇫🇷 Limoges, France

Division of Vascular Medicine, Department of Medicine, Technical University Dresden; 🇩🇪 Dresden, Germany

Fondazione IRCCS; 🇮🇹 Pavia, Italy

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

National Cancer Institute - Antonie van Leeuwenhoek hospital; 🇳🇱 Amsterdam, Netherlands

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain