NCT00423683

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer
• Thromboembolism

Interventions

Type	Name	Description
DRUG	Arixtra alone	Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
DEVICE	Arixtra + filter	Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-01-18
• Last updated: 2016-06-08
• Results posted: 2016-05-03

Locations

1 site across 1 country: United States