Clinical trial NCT00245856: Treatment of Upper Extremity Deep-Vein Thrombosis
Official title: Treatment of Upper Extremity Deep-Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep-Vein Thrombosis
Keywords: Upper Extremity Deep-Vein Thrombosis
DVT
Fragmin
Deep-Vein Thrombosis
Thrombosis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-10-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants That Died at 3 Months
timeFrame: 3 months
measure: New Venous Thromboembolism at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Bleeding Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Department of Veterans Affairs Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
name: Suman W. Rathbun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: