Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423683
Status:
TERMINATED
Last Update Posted:
2016-06-08
First Post:
2007-01-17
Brief Title:
Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study accrual stopped due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None