Deep-Vein Thrombosis Clinical Trial
Official title:
Treatment of Upper Extremity Deep-Vein Thrombosis
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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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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