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Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)

Arixtra alone

Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Arixtra + filter

Myra Barginear, MD

Daniel R. Budman, MD

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 a 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.

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 Inferior Vena Cava (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 Deep Vein thrombosis (DVT). This will also include completion of a quality of life questionnaire.

Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism

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

Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

GlaxoSmithKline

Northwell Health

Interim Chief, Division of Oncology

2 Arixtra+ Filter

Arixtra Alone

Arixtra treatment without inferior vena cava filter

1- Arixtra Alone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Valerie Blake

Arixtra

Arixtra and Filter

Adverse Outcomes

Arm 1 Arixtra

Arm 2 Arixtra + IVC Filter

Overall Survival

33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites

Resolution of DVT

33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites

Resolution of PE

1-Arixtra Alone

Overall Study

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