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

Last updated: May 6, 2016
Sponsor: Northwell Health
Overall Status: Terminated

Phase

3

Condition

Cancer

Venous Thrombosis

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT00423683
IRB # 06-034
  • Ages > 18
  • All Genders

Study 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

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 Design

Total Participants: 64
Study Start date:
January 01, 2007
Estimated Completion Date:
November 30, 2010

Study 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.

Connect with a study center

  • North Shore University Hospital, Monter Cancer Center

    Lake Success, New York 11042
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.