NCT00245856

Treatment of Upper Extremity Deep-Vein Thrombosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep-Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Dalteparin sodium injection	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.
DRUG	Warfarin	Titrated to INR 2-3 through study month 3

Timeline

• Start date: 2002-09-01
• Primary completion: 2009-03-01
• Completion: 2011-12-01
• First posted: 2005-10-28
• Last updated: 2013-02-21
• Results posted: 2013-02-04

Locations

2 sites across 1 country: United States