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

This study is currently recruiting participants.
Verified by North Shore Long Island Jewish Health System, June 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
  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




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