Unsuspected Pulmonary Embolism Clinical Trial
Official title:
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
| NCT number | NCT01727427 |
| Other study ID # | 215/2012 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | December 2017 |
| Verified date | August 2019 |
| Source | G. d'Annunzio University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 695 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Clinical Division of Haematology, Department of Medicine I | Vienna | |
| Canada | Division of Hematology, University of Ottawa | Ottawa | |
| France | 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, Cedex | |
| 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 | |
| Germany | Division of Vascular Medicine, Department of Medicine, Technical University Dresden | Dresden | |
| Italy | 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 | |
| Netherlands | Academic Medical Center | Amsterdam | |
| Netherlands | National Cancer Institute - Antonie van Leeuwenhoek hospital | Amsterdam | |
| Netherlands | Slotervaart hospital | Amsterdam | |
| Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
| Spain | Hospital de Sabadell | Barcelona | |
| Spain | Hospital Vall D'Hebron | Barcelona | |
| Spain | ICO_Hospital Duran i Reynals | Barcelona | |
| Spain | Hospital Clinico Benidorm, Alicante | Benidorm | |
| Spain | Hospital Universitario Insular de Gran Canarias | Las Palmas | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| Spain | Hospital Universitario de Móstoles | Madrid | |
| Spain | Hospital Universitario Infantia Sofia | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Universitario San Carlos | Madrid | |
| Spain | Hospital Santa María Nei | Orense | |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| Spain | Hospital Obispo Polanco | Teruel | |
| Spain | Hospital Nuestra Sra del Prado Talavera de la Reina | Toledo | |
| Spain | Hospital Universitario Dr. Peset | Valencia | |
| United States | D.C. Veterans Affairs Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| G. d'Annunzio University |
United States, Austria, Canada, France, Germany, Italy, Netherlands, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mortality | Overall mortality | one year | |
| Primary | Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis | Suspected recurrent PE with one of the following: new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; new perfusion defect of at least 75% on V/Q lung scan; inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: PE based on objective diagnostic testing or autopsy or 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: abnormal CUS; an intra-luminal filling defect on venography. |
one year | |
| Secondary | Major, clinically relevant non-major bleeding, and minor bleeding | 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 |