Deep-Vein Thrombosis
Conditions
Keywords
Upper Extremity Deep-Vein Thrombosis, DVT, Fragmin, Deep-Vein Thrombosis, Thrombosis
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGWarfarin
Titrated to INR 2-3 through study month 3
Sponsors
Pfizer
University of Oklahoma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram
Exclusion criteria
* Active, clinically significant bleeding * Known hypersensitivity to heparin or low-molecular weight heparin * Currently pregnant or less than 1 week post-partum * Acquired bleeding diathesis * Known inherited bleeding disorder * Renal failure * Extremes of weight * Poor performance status * Unable to return for repeat diagnostic testing or follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Died at 3 Months | 3 months | — |
| New Venous Thromboembolism at 3 Months | 3 months | New DVT or PE at 3 months confirmed by diagnostic testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Events | 3 months | Total major bleeding rate |
Countries
United States
Participant flow
Recruitment details
Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All DVT Treated Patients Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period Two | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All DVT Treated Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 30 |
| Region of Enrollment United States | 67 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 2 / 39 |
| serious Total, serious adverse events | 1 / 28 | 1 / 39 |
Outcome results
Primary
New Venous Thromboembolism at 3 Months
New DVT or PE at 3 months confirmed by diagnostic testing
Time frame: 3 months
Population: All DVT treated patients analyzed together
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All DVT Treated Patients | New Venous Thromboembolism at 3 Months | 0 participants |
Primary
Percentage of Participants That Died at 3 Months
Time frame: 3 months
Population: All DVT treated patients analyzed together
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All DVT Treated Patients | Percentage of Participants That Died at 3 Months | All cause mortality | 8 percentage of participants |
| All DVT Treated Patients | Percentage of Participants That Died at 3 Months | Deaths attributed to DVT/PE | 0 percentage of participants |
Secondary
Bleeding Events
Total major bleeding rate
Time frame: 3 months
Population: All DVT treated patients analyzed together
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All DVT Treated Patients | Bleeding Events | 1 participants |