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

Information source: G. d'Annunzio University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unsuspected Pulmonary Embolism

Intervention: Heparin, fondaparinux, vitamin-K antagonists, aspirin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: G. d'Annunzio University

Official(s) and/or principal investigator(s):
Marcello Di Nisio, MD, PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Overall contact:
Marcello Di Nisio, MD, PhD, Phone: 0039 3283290020, Email: mdinisio@unich.it

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis

Secondary outcome: Major, clinically relevant non-major bleeding, and minor bleeding

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Marcello Di Nisio, MD, PhD, Phone: 0039 3283290020, Email: mdinisio@unich.it

Clinical Division of Haematology, Department of Medicine I, Vienna, Austria; Recruiting
Ingrid Pabinger, Email: ingrid.pabinger@meduniwien.ac.at
Cihan Ay, Email: cihan.ay@meduniwien.ac.at
Johannes Thaler, Sub-Investigator

Division of Hematology, University of Ottawa, Ottawa, Canada; Recruiting
Marc Carrier
Marc Carrier, Email: mcarrier@toh.on.ca

CHU Amiens Picardie, Amiens, France; Active, not recruiting

Arras/Onco Nord Pas de Callais, Loos, Arras, France; Recruiting
Sandro Aquilanti, Email: saquilanti@nordnet.fr
Laetitia Gallois, Email: l.gallois@onco-npdc.fr

Hopital Saint André, Bordeaux, France; Recruiting
Joel Constans, Email: joel.constans@chu-bordeaux.fr
Marion Mangin, Email: marion.mangin@chu-bordeaux.fr

University hospital Centra La Cavale Blanche, Brest, Cedex, France; Recruiting
Francis Couturaud, Email: francis.couturaud@chu-brest.fr

Brest HIA Clermont Tonnerre, Brest, France; Recruiting
Nicolas Paleiron, Email: nicolas.paleiron@free.fr

Montpellier et clinique du parc a Castelnau le nez, Castelnau, France; Active, not recruiting

Hopital G. Montpied Clermont-Ferrand, Clermont, France; Recruiting
Jeannot Schmidt, Email: jschmidt@chu-clermontferrand.fr

AP-HP Hopital Louis Mourier, Colombes, France; Recruiting
Isabelle Mahé, Email: isabelle.mahe@lmr.aphp.fr

Laboratoire d'Hématologie, Dijon, Dijon, France; Recruiting
Nicolas Falvo, Email: nicolas.falvo@chu-dijon.fr

CHU de Limoges, Limoges, France; Active, not recruiting

Centre Hospitalier Lyon-Sud, Lyon, France; Recruiting
Claire Grange, Email: claire.grange@chu-lyon.fr

Hopital Europeen Georges Pompidou, Paris, France; Recruiting
Guy Meyer, Email: guy.meyer@egp.aphp.fr
Helene Mortelette, Email: helene.mortelette@egp.aphp.fr

Hopital Loriboisière, Paris, France; Not yet recruiting
Jean Francois Bergmann, Email: jf.bergmann@lrb.aphp.fr

Hospital Pitie Salpetriere, Paris, France; Active, not recruiting

Service de médecine et Thérapeutique, Saint-Etienne, France; Recruiting
Hervé Decousus, Email: herve.decousus@chu-st-etienne.fr

Division of Vascular Medicine, Department of Medicine, Technical University Dresden, Dresden, Germany; Recruiting
Jan Beyer
Jan Beyer, Email: Beyer.Jan@uniklinikum-dresden.de

Ospedali Riuniti, Bergamo, Italy; Recruiting
Anna Falanga, Email: annafalanga@yahoo.com
Teresa Lerede, Email: tlerede@ospedaliriuniti.bergamo.it

Universita degli Studi G. d'Annunzio Chieti e Pescara, Chieti 66100, Italy; Recruiting
Marcello Di Nisio, MD, PhD, Phone: 0039 328 3290020, Email: mdinisio@unich.it
Ettore Porreca, MD, Sub-Investigator

Malattie Cardiovascolari e Nefrourologiche, Palermo, Italy; Active, not recruiting

Fondazione IRCCS, Pavia, Italy; Recruiting
Franco Piovella, Email: f.piovella@smatteo.pv.it

Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN), Reggio Emilia, Italy; Active, not recruiting

Università dell'Insubria, Varese, Italy; Active, not recruiting

Academic Medical Center, Amsterdam, Netherlands; Recruiting
Harry R Büller, MD PhD, Email: h.r.buller@amc.uva.nl
Suzanne Bleker, MD, Phone: +31 20 5668274, Email: s.m.bleker@amc.uva.nl
Nick van Es, MD, Sub-Investigator

National Cancer Institute - Antonie van Leeuwenhoek hospital, Amsterdam, Netherlands; Recruiting
Joke Baars, MD PhD, Email: j.baars@nki.nl
Suzanne Bleker, MD, Email: s.bleker@nki.nl

Slotervaart hospital, Amsterdam 1066 EC, Netherlands; Recruiting
Hans-Martin Otten, MD, PhD, Phone: +3120 5129333, Ext: 700, Email: Hans-Martin.Otten@slz.nl
Nick van Es, MD, Sub-Investigator

Hospital Clinic i Provincial de Barcelona, Barcelona, Spain; Not yet recruiting
Carme Font i Puig, Email: cfont@clinic.ub.es

Hospital de Sabadell, Barcelona, Spain; Not yet recruiting
José Garcia Ruiz, Email: jgarciaR@tauli.cat
Enrique Gallardo Díaz, Email: egallardo@tauli.cat

Hospital Vall D'Hebron, Barcelona, Spain; Not yet recruiting
Mercedes Biosca Gómez de Tejada, Email: mbiosca@vhebron.net

ICO_Hospital Duran i Reynals, Barcelona, Spain; Not yet recruiting
Maite Antonio Rebollo, Email: mantonio@iconcologia.net

Hospital Clinico Benidorm, Alicante, Benidorm, Spain; Not yet recruiting
Gaspar Esquerdo Galiana, Email: gasparesquerdo@yahoo.es

Hospital Universitario Insular de Gran Canarias, Las Palmas, Spain; Not yet recruiting
Elene Vicente Rubio, Email: elenavrubio@yahoo.es

Hospital General Universitario Gregorio Marañón, Madrid, Spain; Not yet recruiting
Andrés Jesús Muñoz, Email: andresmunmar@hotmail.com

Hospital Universitario de Móstoles, Madrid, Spain; Not yet recruiting
Silvia García Adrián, Email: silvia.garciaa@salud.madrid.org

Hospital Universitario Infantia Sofia, Madrid, Spain; Not yet recruiting
Mar Martin del Pozo, Email: mar.martin.pozo@googlemail.com
Olga Madridano Cobo, Email: olga.madridano@salud.madrid.org

Hospital Universitario La Paz, Madrid, Spain; Not yet recruiting
Virginia Martínez Martin, Email: virginmarin9@hotmail.com
Margarita Sánchez-Pastor Ruiz, Email: margaspastor@hotmail.com

Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain; Not yet recruiting
Ignacio García Escobar, Email: naxto@hotmail.com

Hospital Universitario Ramón y Cajal, Madrid, Spain; Not yet recruiting
Vanessa Pachón Olmos, Email: li_tor@hotmail.com

Hospital Universitario San Carlos, Madrid, Spain; Not yet recruiting
Pedro Pérez Segura, Email: pedro.perez@salud.madrid.org

Hospital Santa María Nei, Orense, Spain; Not yet recruiting
Mercedes Salgado Fernández, Email: mercedes.salgado.fernandez@sergas.es

Hospital Universitario de Salamanca, Salamanca, Spain; Not yet recruiting
Luis Miguel Navarro, Email: lmnavarro@saludcastillayleon.es
Juan Carlos Adansa Klain, Email: unidad_eecc@usal.es

Hospital Obispo Polanco, Teruel, Spain; Not yet recruiting
Ana Isabel Ferrer Pérez, Email: anafp2001@yahoo.es

Hospital Nuestra Sra del Prado Talavera de la Reina, Toledo, Spain; Not yet recruiting
Ana María González Ageitos, Email: anageitos@gmail.com

Hospital Universitario Dr. Peset, Valencia, Spain; Not yet recruiting
Jose Muñoz Langa, Email: munyoz_joslan@gva.es

D.C. Veterans Affairs Medical Center, Washington, District of Columbia 20422, United States; Recruiting
Frederick Rickles, Email: frederick.rickles@gmail.com
Anita Aggarwal, Email: anita.aggarwal@va.gov

Additional Information

Starting date: November 2012
Last updated: August 12, 2015

Page last updated: August 23, 2015

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