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

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.

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.