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A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Thromboembolism

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Trial Information

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.


Inclusion Criteria:



- Cancer patient, over 18 years of age, acute radiographically confirmed denovo DVT or
PE.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Death due to any cause, event free survival.

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Myra Barginear, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Shore University Hospital Monter Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

IRB # 06-034

NCT ID:

NCT00423683

Start Date:

January 2007

Completion Date:

November 2010

Related Keywords:

  • Cancer
  • Thromboembolism
  • Cancer
  • thromboembolism
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

Name

Location

North Shore University HospitalManhasset, New York  11030