Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
Condition: Cancer; Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Arixtra alone; Arixtra + filter
Intervention description: Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt); Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; thromboembolism

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.
    

Eligibility 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.