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

This study is currently recruiting participants.
Verified December 2016 by Marcello Di Nisio, G. d'Annunzio University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727427
First Posted: November 16, 2012
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcello Di Nisio, G. d'Annunzio University
November 7, 2012
November 16, 2012
December 5, 2016
November 2012
November 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01727427 on ClinicalTrials.gov Archive Site
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.

Same as current
Mortality [ Time Frame: one year ]
Overall mortality
Same as current
 
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Unsuspected Pulmonary Embolism
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)
Anticoagulants, aspirin
Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration
Intervention: Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
610
November 2017
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Marcello Di Nisio, MD, PhD 0039 3283290020 mdinisio@unich.it
Austria,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   United States
 
 
NCT01727427
215/2012
Yes
Not Provided
Not Provided
Marcello Di Nisio, G. d'Annunzio University
G. d'Annunzio University
Not Provided
Principal Investigator: Marcello Di Nisio, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
G. d'Annunzio University
December 2016