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

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ClinicalTrials.gov Identifier: NCT00423683
Recruitment Status : Terminated (Study accrual stopped due to poor accrual.)
First Posted : January 18, 2007
Results First Posted : May 3, 2016
Last Update Posted : June 8, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Daniel Budman, Northwell Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Thromboembolism Drug: Arixtra alone Device: Arixtra + filter Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
Study Start Date : January 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1- Arixtra Alone
Arixtra Alone
 Drug: Arixtra alone
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
Other Name: Arixtra
Active Comparator: 2 Arixtra+ filter
Arixtra + filter
 Device: Arixtra + filter
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Other Name: IVC filter and Arixtra


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Outcomes [ Time Frame: 3 years or until death ]
    Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years or until death ]
  2. Resolution of DVT [ Time Frame: 3 years or until death ]
  3. Resolution of PE [ Time Frame: 3 years or until death ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documentation of cancer.
  • The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will be documented in the patient's chart and included in the data.
  • Age > 18 years
  • An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
  • No past medical history of a prior thrombus or known thrombophilia

Exclusion Criteria

  • Patients are not eligible for this study if they receive therapeutic doses of any heparin for more than 72 hours before randomization 31.
  • Already receiving oral anticoagulant therapy 31.
  • Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a creatinine clearance <30 mL/min 31.
  • Platelet count of less than 50,000 per cubic millimeter
  • Bleeding from the gastrointestinal tract that requires blood transfusion (s), intracranial bleeding or retroperitoneal bleeding.
  • An indication for thrombolysis
  • Allergy to iodine
  • Hereditary thrombophilia
  • Pregnancy
  • Likelihood of noncompliance
  • It is contraindicated to anticoagulate patients with brain metastasis secondary to melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these patients have a Venous Thromboembolism (VTE), it is standard of care for these patients to have a CT of their head to evaluate if there is metastasis to the brain before they are anticoagulated 38. If these patients do have brain metastasis, they will not be included in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423683


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
GlaxoSmithKline
Investigators
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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
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Responsible Party: Daniel Budman, Interim Chief, Division of Oncology, Northwell Health
ClinicalTrials.gov Identifier: NCT00423683    
Other Study ID Numbers: IRB # 06-034
First Posted: January 18, 2007    Key Record Dates
Results First Posted: May 3, 2016
Last Update Posted: June 8, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel Budman, Northwell Health:
Cancer
thromboembolism
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
PENTA
Fondaparinux
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents