Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
|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.|
|ClinicalTrials.gov Identifier: NCT01727427|
Recruitment Status : Recruiting
First Posted : November 16, 2012
Last Update Posted : December 5, 2016
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.
|Condition or disease||Intervention/treatment|
|Unsuspected Pulmonary Embolism||Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin|
|Study Type :||Observational|
|Estimated Enrollment :||610 participants|
|Official Title:||Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration
Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin
Parenteral or oral anticoagulant Antiplatelet agent
- Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis [ Time Frame: one year ]
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.
- 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.
- Mortality [ Time Frame: one year ]Overall mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727427
|Contact: Marcello Di Nisio, MD, PhD||0039 email@example.com|
Show 46 Study Locations
|Principal Investigator:||Marcello Di Nisio, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|