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

NCT ID: NCT01727427

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

695 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Unsuspected Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anticoagulants, aspirin

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

Heparin, fondaparinux, vitamin-K antagonists, aspirin

Intervention Type DRUG

Parenteral or oral anticoagulant Antiplatelet agent

Interventions

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Heparin, fondaparinux, vitamin-K antagonists, aspirin

Parenteral or oral anticoagulant Antiplatelet agent

Intervention Type DRUG

Other Intervention Names

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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)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Marcello Di Nisio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcello Di Nisio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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D.C. Veterans Affairs Medical Center

Washington D.C., District of Columbia, United States

Site Status

Clinical Division of Haematology, Department of Medicine I

Vienna, , Austria

Site Status

Division of Hematology, University of Ottawa

Ottawa, , Canada

Site Status

CHU Amiens Picardie

Amiens, , France

Site Status

Arras/Onco Nord Pas de Callais, Loos

Arras, , France

Site Status

Hopital Saint André

Bordeaux, , France

Site Status

Brest HIA Clermont Tonnerre

Brest, , France

Site Status

University hospital Centra La Cavale Blanche

Brest, , France

Site Status

Montpellier et clinique du parc a Castelnau le nez

Castelnau, , France

Site Status

Hopital G. Montpied Clermont-Ferrand

Clermont, , France

Site Status

AP-HP Hopital Louis Mourier

Colombes, , France

Site Status

Laboratoire d'Hématologie, Dijon

Dijon, , France

Site Status

CHU de Limoges

Limoges, , France

Site Status

Centre Hospitalier Lyon-Sud

Lyon, , France

Site Status

Hopital Europeen Georges Pompidou

Paris, , France

Site Status

Hopital Loriboisière

Paris, , France

Site Status

Hospital Pitie Salpetriere

Paris, , France

Site Status

Service de médecine et Thérapeutique

Saint-Etienne, , France

Site Status

Division of Vascular Medicine, Department of Medicine, Technical University Dresden

Dresden, , Germany

Site Status

Ospedali Riuniti

Bergamo, , Italy

Site Status

Universita degli Studi G. d'Annunzio Chieti e Pescara

Chieti, , Italy

Site Status

Malattie Cardiovascolari e Nefrourologiche

Palermo, , Italy

Site Status

Fondazione IRCCS

Pavia, , Italy

Site Status

Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)

Reggio Emilia, , Italy

Site Status

Università dell'Insubria

Varese, , Italy

Site Status

Slotervaart hospital

Amsterdam, , Netherlands

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

National Cancer Institute - Antonie van Leeuwenhoek hospital

Amsterdam, , Netherlands

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital de Sabadell

Barcelona, , Spain

Site Status

Hospital Vall D'Hebron

Barcelona, , Spain

Site Status

ICO_Hospital Duran i Reynals

Barcelona, , Spain

Site Status

Hospital Clinico Benidorm, Alicante

Benidorm, , Spain

Site Status

Hospital Universitario Insular de Gran Canarias

Las Palmas, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario de Móstoles

Madrid, , Spain

Site Status

Hospital Universitario Infantia Sofia

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario San Carlos

Madrid, , Spain

Site Status

Hospital Santa María Nei

Ourense, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Obispo Polanco

Teruel, , Spain

Site Status

Hospital Nuestra Sra del Prado Talavera de la Reina

Toledo, , Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status

Countries

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United States Austria Canada France Germany Italy Netherlands Spain

References

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Kraaijpoel N, Bleker SM, Meyer G, Mahe I, Munoz A, Bertoletti L, Bartels-Rutten A, Beyer-Westendorf J, Porreca E, Boulon C, van Es N, Iosub DI, Couturaud F, Biosca M, Lerede T, Lacroix P, Maraveyas A, Aggarwal A, Girard P, Buller HR, Di Nisio M; UPE investigators. Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study. J Clin Oncol. 2019 Jul 10;37(20):1713-1720. doi: 10.1200/JCO.18.01977. Epub 2019 May 22.

Reference Type DERIVED
PMID: 31116676 (View on PubMed)

Other Identifiers

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215/2012

Identifier Type: -

Identifier Source: org_study_id

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