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Completed

NCT Number: NCT00245856

Treatment of Upper Extremity Deep-Vein Thrombosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Veterans Affairs Medical Center, Oklahoma City, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalteparin sodium injection

Drug

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.

Other names: Fragmin

Warfarin

Drug

Titrated to INR 2-3 through study month 3

Primary outcomes

  1. Percentage of Participants That Died at 3 Months

    Time frame: 3 months

  2. New Venous Thromboembolism at 3 Months

    Time frame: 3 months

    New DVT or PE at 3 months confirmed by diagnostic testing

Secondary outcomes

  1. Bleeding Events

    Time frame: 3 months

    Total major bleeding rate

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2002
Primary completion
2009
Study completion
2011
First posted
Oct 28, 2005
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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