| January 17, 2007 |
| August 4, 2009 |
| January 2007 |
| December 2009 (final data collection date for primary outcome measure) |
| Death due to any cause, event free survival. [ Time Frame: One year ] [ Designated as safety issue: Yes ] |
| Death due to any cause, event free survival. |
| Complete list of historical versions of study NCT00423683 on ClinicalTrials.gov Archive Site |
- Occurrence of pulmonary embolism, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- major bleeding, thrombophlebitis, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- cellulitis secondary to IV filter, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- thrombosis of the IVC filter and quality of life. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
|
- Occurrence of pulmonary embolism,
- major bleeding, thrombophlebitis,
- cellulitis secondary to IV filter,
- thrombosis of the IVC filter and quality of life.
|
| |
| Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism |
| A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism |
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. |
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 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 DVT. This will also include completion of a quality of life questionnaire. |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: Arixtra
- Device: Inferior Vena Cava Filter (with or without)
- Drug: Arixtra alone
- Device: Arixtra + filter
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- Experimental: Arixtra Alone
- Active Comparator: Arixtra + filter
|
| |
| |
| Recruiting |
| 106 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Cancer patient, over 18 years of age, acute radiographically confirmed denovo DVT or PE.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00423683 |
| Daniel R. Budman, MD, North Shore Long Island Jewish Health System |
| IRB # 06-034 |
| North Shore Long Island Jewish Health System |
| GlaxoSmithKline |
| Principal Investigator: |
Myra Barginear, MD |
North Shore University Hospital Monter Cancer Center |
|
| Principal Investigator: |
Daniel R. Budman, MD |
North Shore University Hospital Monter Cancer Center |
|
|
| North Shore Long Island Jewish Health System |
| August 2009 |
