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

Sponsor:	North Shore Long Island Jewish Health System
Collaborator:	GlaxoSmithKline
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00423683

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

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

No publications provided

Responsible Party:	North Shore Long Island Jewish Health System ( Daniel R. Budman, MD )
Study ID Numbers:	IRB # 06-034
Study First Received:	January 17, 2007
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00423683 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:

Cancer
thromboembolism

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fondaparinux
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism

Thromboembolism
Thrombosis
Org 31540
Pharmacologic Actions
Fibrin Modulating Agents
Embolism and Thrombosis
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2009