Clinical trial NCT00423683: Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
Official title: A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Thromboembolism
Keywords: Cancer
thromboembolism
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-01-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Adverse Outcomes
timeFrame: 3 years or until death
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years or until death
measure: Resolution of DVT
timeFrame: 3 years or until death
measure: Resolution of PE
timeFrame: 3 years or until death
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital Monter Cancer Center
name: Myra Barginear, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore University Hospital Monter Cancer Center
name: Daniel R. Budman, MD
role: PRINCIPAL_INVESTIGATOR
References: