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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer, Thromboembolism

Intervention / Treatment
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* Drug: Arixtra alone
* Device: Arixtra + filter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- Arixtra Alone<br>Arixtra Alone | Drug: Arixtra alone<br>* Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)<br>* Other names: Arixtra;|
| Active Comparator: 2 Arixtra+ filter<br>Arixtra + filter | Device: Arixtra + filter<br>* Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.<br>* Other names: IVC filter and Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Outcomes | Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs | 3 years or until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years or until death | 
| Resolution of DVT |  | 3 years or until death | 
| Resolution of PE |  | 3 years or until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, thromboembolism