Treatment of Upper Extremity Deep-Vein Thrombosis

Phase 4

Completed

• Conditions: Deep-Vein Thrombosis
• Interventions: Drug: Dalteparin sodium injection; Drug: Warfarin

• Registration Number: NCT00245856
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Primary Completion: 2009-03
• Study Completion: 2011-12
• Status Verified: 2013-02
• Results First Submitted: 2013-02-01
• Results First Submitted QC: 2013-02-01
• Results First Posted: 2013-02-04
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of Upper Extremity DVT	Dalteparin sodium injection	Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
Treatment of Upper Extremity DVT	Warfarin	Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bleeding Events	3 months	Total major bleeding rate

Trial Locations

Locations (2)

Department of Veterans Affairs Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Oklahoma Health Science Center; 🇺🇸 Oklahoma City, Oklahoma, United States