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| ID | Type | Description | Link |
|---|---|---|---|
| ORA-20020622 | Other Identifier | University of Oklahoma Office of Research Administration |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.
Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.
All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.
All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of Upper Extremity DVT | Experimental | Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin sodium injection | Drug | 200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Died at 3 Months | 3 months | |
| New Venous Thromboembolism at 3 Months | New DVT or PE at 3 months confirmed by diagnostic testing | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Events | Total major bleeding rate | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman W. Rathbun, M.D. | University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs Medical Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| University of Oklahoma Health Science Center |
Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.
Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin + Warfarin | 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study. |
| FG001 | Dalteparin Only | 200 units/kg for one month At month one, dosage reduction based on weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One |
| |||||||||||||
| Period Two |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All DVT Treated Patients | Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months |
| 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 | Percentage of Participants That Died at 3 Months | All DVT treated patients analyzed together | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalteparin + Warfarin | 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suman Rathbun MD | University of Oklahoma Health Sciences Center | 4052714742 | 44773 | suman-rathbun@ouhsc.edu |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D056824 | Upper Extremity Deep Vein Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| Warfarin | Drug | Titrated to INR 2-3 through study month 3 |
|
| Oklahoma City |
| Oklahoma |
| 73117 |
| United States |
| NOT COMPLETED |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | New Venous Thromboembolism at 3 Months | New DVT or PE at 3 months confirmed by diagnostic testing | All DVT treated patients analyzed together | Posted | Number | 95% Confidence Interval | participants | 3 months |
|
|
|
| Secondary | Bleeding Events | Total major bleeding rate | All DVT treated patients analyzed together | Posted | Number | 95% Confidence Interval | participants | 3 months |
|
|
|
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | Dalteparin Only | 200 units/kg for one month At month one, dosage reduction based on weight | 1 | 39 | 2 | 39 |
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| D002241 |
| Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |