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

Primary Purpose

Cancer, Thromboembolism

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arixtra alone
Arixtra + filter
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1- Arixtra Alone

2 Arixtra+ filter

Arm Description

Arixtra Alone

Arixtra + filter

Outcomes

Primary Outcome Measures

Adverse Outcomes
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

Secondary Outcome Measures

Overall Survival
Resolution of DVT
Resolution of PE

Full Information

First Posted
January 17, 2007
Last Updated
May 6, 2016
Sponsor
Northwell Health
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00423683
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Study accrual stopped due to poor accrual.
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Thromboembolism
Keywords
Cancer, thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1- Arixtra Alone
Arm Type
Experimental
Arm Description
Arixtra Alone
Arm Title
2 Arixtra+ filter
Arm Type
Active Comparator
Arm Description
Arixtra + filter
Intervention Type
Drug
Intervention Name(s)
Arixtra alone
Other Intervention Name(s)
Arixtra
Intervention Description
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
Intervention Type
Device
Intervention Name(s)
Arixtra + filter
Other Intervention Name(s)
IVC filter and Arixtra
Intervention Description
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Primary Outcome Measure Information:
Title
Adverse Outcomes
Description
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs
Time Frame
3 years or until death
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years or until death
Title
Resolution of DVT
Time Frame
3 years or until death
Title
Resolution of PE
Time Frame
3 years or until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myra Barginear, MD
Organizational Affiliation
North Shore University Hospital Monter Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel R. Budman, MD
Organizational Affiliation
North Shore University Hospital Monter Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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