Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.
In a phase II trial, high risk hospitalized cancer patients will be enrolled and randomized to standard dose enoxaparin versus intermediate dose (weight adjusted) enoxaparin thromboprophylaxis. Study subjects will be administered enoxaparin during hospitalization in a double-blinded manner. Following completion of 14 days, the study arms will be unblinded and lower extremity ultrasound performed on the standard dose enoxaparin arm in order to more accurately determine the overall cumulative incidence of thrombosis in this group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
Time frame: 17 days only measured in Arm A (Standard dose enoxaparin)
Number Participants With Major Hemorrhage
Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm
Time frame: 14 days
Number of Symptomatic Venous Thromboembolic Events (VTE)
Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).
Time frame: 14 days
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