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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 Months

New 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

Page last updated: August 20, 2015

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