Status:
TERMINATED
Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cancer
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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...
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.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00423683
Start Date
January 1 2007
End Date
November 1 2010
Last Update
June 8 2016
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030