Treatment of Upper Extremity Deep-Vein Thrombosis
Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deep-Vein Thrombosis
Intervention: Dalteparin sodium injection (Drug); Warfarin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s): Suman W. Rathbun, M.D., Principal Investigator, Affiliation: University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
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.
Clinical Details
Official title: Treatment of Upper Extremity Deep-Vein Thrombosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants That Died at 3 MonthsNew Venous Thromboembolism at 3 Months
Secondary outcome: Bleeding Events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Department of Veterans Affairs Medical Center, Oklahoma City, Oklahoma 73104, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma 73117, United States
Additional Information
Starting date: September 2002
Last updated: February 15, 2013
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