Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cancer Thromboembolism	Drug: Arixtra Device: Inferior Vena Cava Filter (with or without) Drug: Arixtra alone Device: Arixtra + filter	Phase III

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Fondaparinux sodium ORG 31540

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Death due to any cause, event free survival. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of pulmonary embolism, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
major bleeding, thrombophlebitis, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
cellulitis secondary to IV filter, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
thrombosis of the IVC filter and quality of life. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	106
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1- Arixtra Alone: Experimental Arixtra Alone	Drug: Arixtra Arixtra Drug: Arixtra alone Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
2 Arixtra+ filter: Active Comparator Arixtra + filter	Device: Inferior Vena Cava Filter (with or without) IVC filter - filter of choice by radiologist Device: Arixtra + filter Atrixa as daily injections similar to arm I and placement of IVC filter. Device: Arixtra + filter Arixtra subq injection + IVC filter

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423683

Contacts


Contact: Myra Barginear, MD	516-975-2348	m_barginear@hotmail.com

Locations


United States, New York
	North Shore University Hospital, Monter Cancer Center	Recruiting
	Lake Success, New York, United States, 11042
	Contact: Myra Barginear, MD 516-975-2348 m_barginear@hotmail.com
	Contact: Daniel Budman, MD 516-719-8958 dbudman@nshs.edu
	Principal Investigator: Myra Barginear, MD
	Sub-Investigator: Daniel Budman, MD
	Sub-Investigator: Anu Chandok, MD
	Sub-Investigator: Thomas Bradley, MD
	Sub-Investigator: Iulianna Shapira, MD
	North Shore University Hospital	Recruiting
	Manhasset, New York, United States, 11030
	Contact: Myra Barginear, MD 516-975-2348 m_barginear@hotmail.com
	Principal Investigator: Myra Barginear, MD
	Sub-Investigator: Daniel Budman,, MD
	Sub-Investigator: Anu Chandok, MD
	Sub-Investigator: Thomas Bradley,, MD
	Sub-Investigator: Iulianna Shapira, MD

Sponsors and Collaborators

North Shore Long Island Jewish Health System

GlaxoSmithKline

Investigators


Principal Investigator:	Myra Barginear, MD	North Shore University Hospital Monter Cancer Center

Principal Investigator:	Daniel R. Budman, MD	North Shore University Hospital Monter Cancer Center

More Information

Responsible Party:	North Shore Long Island Jewish Health System ( Daniel R. Budman, MD )
Study ID Numbers:	IRB # 06-034
First Received:	January 17, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00423683
Health Authority:	United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:

Cancer

thromboembolism

Study placed in the following topic categories:

Embolism and Thrombosis

Embolism

Vascular Diseases

Fondaparinux

Venous Thromboembolism

Org 31540

Thrombosis

Thromboembolism

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008

Sponsors and Collaborators:	North Shore Long Island Jewish Health System GlaxoSmithKline
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00423683