Not provided
Not provided
Not provided
Not provided
Not provided
Study accrual stopped due to poor accrual.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Arixtra Alone | Experimental | Arixtra Alone |
|
| 2 Arixtra+ filter | Active Comparator | Arixtra + filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arixtra alone | Drug | Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Outcomes | Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs | 3 years or until death |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years or until death | |
| Resolution of DVT | 3 years or until death | |
| Resolution of PE |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myra Barginear, MD | North Shore University Hospital Monter Cancer Center | Principal Investigator |
| Daniel R. Budman, MD | North Shore University Hospital Monter Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
recruitment was slowed due to newly approved medications so study was stopped early.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2 Arixtra+ Filter | Arixtra subq injection + IVC filter |
| FG001 | 1-Arixtra Alone | Arixtra treatment without inferior vena cava filter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2 Arixtra+ Filter | Arixtra subq injection + IVC filter |
| BG001 | 1- Arixtra Alone | Arixtra treatment without inferior vena cava filter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Outcomes | Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs | Posted | Number | percentage of participants | 3 years or until death |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Arixtra+ Filter | Arixtra subq injection + IVC filter |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Blake | North Shore LIJ Health System | 516-562-0100 | vblake@nshs.edu |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Arixtra + filter | Device | Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter. |
|
|
| 3 years or until death |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | days | 3 years or until death |
|
|
|
| Secondary | Resolution of DVT | 33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites | Posted | Number | percentage of DVT sites | 3 years or until death | DVT sites | Participants |
|
|
|
| Secondary | Resolution of PE | 33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites | Posted | Number | percentage of PE sites | 3 years or until death | PE sites | Participants |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Arixtra Alone | Arixtra anti coagulation alone | 0 | 33 | 0 | 33 |
Not provided