- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00423683
Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
May 6, 2016 updated by: Daniel Budman, Northwell Health
A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Manhasset, New York, United States, 11030
- North Shore University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1- Arixtra Alone
Arixtra Alone
|
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
Other Names:
|
Active Comparator: 2 Arixtra+ filter
Arixtra + filter
|
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Outcomes
Time Frame: 3 years or until death
|
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs
|
3 years or until death
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 3 years or until death
|
3 years or until death
|
Resolution of DVT
Time Frame: 3 years or until death
|
3 years or until death
|
Resolution of PE
Time Frame: 3 years or until death
|
3 years or until death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
January 17, 2007
First Submitted That Met QC Criteria
January 17, 2007
First Posted (Estimate)
January 18, 2007
Study Record Updates
Last Update Posted (Estimate)
June 8, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Fondaparinux
- PENTA
Other Study ID Numbers
- IRB # 06-034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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