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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00423683
• Other study ID #: IRB # 06-034
• Status: Terminated
• Phase: Phase 3
• First received: January 17, 2007
• Last updated: June 29, 2012
• Start date: January 2007
• Est. completion date: November 2010

Study information

• Verified date: June 2012
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Arixtra
Arixtra

Device:
• Inferior Vena Cava Filter (with or without)
IVC filter - filter of choice by radiologist

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

Device:
• Arixtra + filter
Atrixa as daily injections similar to arm I and placement of IVC filter.
• Arixtra + filter
Arixtra subq injection + IVC filter

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death due to any cause, event free survival.		One year	Yes
Secondary	Occurrence of pulmonary embolism,		One year	Yes
Secondary	major bleeding, thrombophlebitis,		One year	Yes
Secondary	cellulitis secondary to IV filter,		One year	Yes
Secondary	thrombosis of the IVC filter and quality of life.		One year	Yes