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

August 7, 2019 updated by: Marcello Di Nisio, G. d'Annunzio University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

695

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Clinical Division of Haematology, Department of Medicine I
  • Canada
      • Ottawa, Canada
        • Division of Hematology, University of Ottawa
  • France
      • Amiens, France
        • CHU Amiens Picardie
      • Arras, France
        • Arras/Onco Nord Pas de Callais, Loos
      • Bordeaux, France
        • Hopital Saint Andre
      • Brest, France
        • Brest HIA Clermont Tonnerre
      • Brest, Cedex, France
        • University hospital Centra La Cavale Blanche
      • Castelnau, France
        • Montpellier et clinique du parc a Castelnau le nez
      • Clermont, France
        • Hopital G. Montpied Clermont-Ferrand
      • Colombes, France
        • AP-HP Hopital Louis Mourier
      • Dijon, France
        • Laboratoire d'Hématologie, Dijon
      • Limoges, France
        • CHU de Limoges
      • Lyon, France
        • Centre Hospitalier Lyon-Sud
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hopital Loriboisière
      • Paris, France
        • Hospital Pitie Salpetriere
      • Saint-Etienne, France
        • Service de Medecine et Therapeutique
  • Germany
      • Dresden, Germany
        • Division of Vascular Medicine, Department of Medicine, Technical University Dresden
  • Italy
      • Bergamo, Italy
        • Ospedali Riuniti
      • Chieti, Italy, 66100
        • Universita degli Studi G. d'Annunzio Chieti e Pescara
      • Palermo, Italy
        • Malattie Cardiovascolari e Nefrourologiche
      • Pavia, Italy
        • Fondazione IRCCS
      • Reggio Emilia, Italy
        • Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)
      • Varese, Italy
        • Università dell'Insubria
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Amsterdam, Netherlands, 1066 EC
        • Slotervaart Hospital
      • Amsterdam, Netherlands
        • National Cancer Institute - Antonie van Leeuwenhoek hospital
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital de Sabadell
      • Barcelona, Spain
        • ICO_Hospital Duran i Reynals
      • Benidorm, Spain
        • Hospital Clinico Benidorm, Alicante
      • Las Palmas, Spain
        • Hospital Universitario Insular de Gran Canarias
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain
        • Hospital Universitario de Mostoles
      • Madrid, Spain
        • Hospital Universitario Infantia Sofia
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Madrid, Spain
        • Hospital Universitario San Carlos
      • Orense, Spain
        • Hospital Santa María Nei
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Teruel, Spain
        • Hospital Obispo Polanco
      • Toledo, Spain
        • Hospital Nuestra Sra del Prado Talavera de la Reina
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • D.C. Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anticoagulants, aspirin
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: one year
Overall mortality
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Investigators

  • Principal Investigator: Marcello Di Nisio, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 215/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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