Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulants, aspirin | Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin, fondaparinux, vitamin-K antagonists, aspirin | Drug | Parenteral or oral anticoagulant Antiplatelet agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis | Suspected recurrent PE with one of the following:
Fatal PE is:
Suspected (recurrent) DVT with one of the following findings:
| one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Overall mortality | one year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcello Di Nisio, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D.C. Veterans Affairs Medical Center | Washington D.C. | District of Columbia | 20422 | United States | ||
| Clinical Division of Haematology, Department of Medicine I |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31116676 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| one year |
| Vienna |
| Austria |
| Division of Hematology, University of Ottawa | Ottawa | Canada |
| 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 | 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 | France |
| Division of Vascular Medicine, Department of Medicine, Technical University Dresden | Dresden | Germany |
| Ospedali Riuniti | Bergamo | Italy |
| Universita degli Studi G. d'Annunzio Chieti e Pescara | Chieti | 66100 | 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 | Italy |
| Slotervaart hospital | Amsterdam | 1066 EC | Netherlands |
| Academic Medical Center | Amsterdam | Netherlands |
| National Cancer Institute - Antonie van Leeuwenhoek hospital | Amsterdam | Netherlands |
| 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 | Ourense | 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 | Spain |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006493 | Heparin |
| D000077425 | Fondaparinux |
| D001241 | Aspirin |
| D017984 | Enoxaparin |
| D017985 | Dalteparin |
| D017762 | Nadroparin |
| D000078222 | Tinzaparin |
| C411345 | bemiparin |
| D014859 | Warfarin |
| D000074 | Acenocoumarol |
| D010644 | Phenprocoumon |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D009844 | Oligosaccharides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D006495 | Heparin, Low-Molecular-Weight |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
Not provided
Not provided