Treatment of Upper Extremity Deep-Vein Thrombosis
|ClinicalTrials.gov Identifier: NCT00245856|
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : February 4, 2013
Last Update Posted : February 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Deep-Vein Thrombosis||Drug: Dalteparin sodium injection Drug: Warfarin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Upper Extremity Deep-Vein Thrombosis|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||December 2011|
Experimental: Treatment of Upper Extremity DVT
Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
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.
Other Name: Fragmin
Titrated to INR 2-3 through study month 3
- Percentage of Participants That Died at 3 Months [ Time Frame: 3 months ]
- New Venous Thromboembolism at 3 Months [ Time Frame: 3 months ]New DVT or PE at 3 months confirmed by diagnostic testing
- Bleeding Events [ Time Frame: 3 months ]Total major bleeding rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245856
|United States, Oklahoma|
|Department of Veterans Affairs Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|University of Oklahoma Health Science Center|
|Oklahoma City, Oklahoma, United States, 73117|
|Principal Investigator:||Suman W. Rathbun, M.D.||University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section|