Treatment of Upper Extremity Deep-Vein Thrombosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Upper Extremity Deep-Vein Thrombosis

Conditions
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Deep-Vein Thrombosis

Intervention / Treatment
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* Drug: Dalteparin sodium injection
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of Upper Extremity DVT<br>Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT | Drug: Dalteparin sodium injection<br>* 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.<br>* Other names: Fragmin;Drug: Warfarin<br>* Titrated to INR 2-3 through study month 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Events | Total major bleeding rate | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity Deep-Vein Thrombosis, DVT, Fragmin, Deep-Vein Thrombosis, Thrombosis