A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
The development of clots is a potentially deadly complication in many cancer patients. The
current optimal treatment is unknown. Evidence supporting the effectiveness of the use of
Inferior Vena Caval Filters is lacking. This study will compare the two standard of care
treatment options: anticoagulation with or without an inferior vena cava filter. The
anticoagulation medication chosen will be Arixtra and it will be given once a day as an
injection. Patients will be called at various intervals to monitor their signs and symptoms
of new thromboembolisms. Patients will be equally randomized to receive either Arixtra with
or without placement of an IVC filter. Fifty three patients are expected to be enrolled in
each arm. Patients will be monitored for 90 days after study enrollment. Monitoring will
include telephone calls and physician visits and repeat radiologists if the patient is
symptomatic of a DVT. This will also include completion of a quality of life questionnaire.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Death due to any cause, event free survival.
One year
Yes
Myra Barginear, MD
Principal Investigator
North Shore University Hospital Monter Cancer Center
United States: Food and Drug Administration
IRB # 06-034
NCT00423683
January 2007
November 2010
Name | Location |
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North Shore University Hospital | Manhasset, New York 11030 |