Treatment of Upper Extremity Deep-Vein Thrombosis

Deep-Vein Thrombosis Clinical Trial

Official title:

Treatment of Upper Extremity Deep-Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245856
• Other study ID #: 10206
• Secondary ID: ORA-20020622
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: February 15, 2013
• Start date: September 2002
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep-Vein Thrombosis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

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.
• Warfarin
Titrated to INR 2-3 through study month 3

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Medical Center	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants That Died at 3 Months		3 months	Yes
Primary	New Venous Thromboembolism at 3 Months	New DVT or PE at 3 months confirmed by diagnostic testing	3 months	No
Secondary	Bleeding Events	Total major bleeding rate	3 months	Yes