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Treatment of Upper Extremity Deep-Vein Thrombosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245856
First Posted: October 28, 2005
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma
  Purpose
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.

Condition Intervention Phase
Deep-Vein Thrombosis Drug: Dalteparin sodium injection Drug: Warfarin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Upper Extremity Deep-Vein Thrombosis

Resource links provided by NLM:


Further study details as provided by Suman Rathbun, University of Oklahoma:

Primary Outcome Measures:
  • Percentage of Participants That Died at 3 Months [ Time Frame: 3 months ]
  • New Venous Thromboembolism at 3 Months [ Time Frame: 3 months ]
    New DVT or PE at 3 months confirmed by diagnostic testing


Secondary Outcome Measures:
  • Bleeding Events [ Time Frame: 3 months ]
    Total major bleeding rate


Enrollment: 67
Study Start Date: September 2002
Study Completion Date: December 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment of Upper Extremity DVT
Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
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.
Other Name: Fragmin
Drug: Warfarin
Titrated to INR 2-3 through study month 3

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245856


Locations
United States, Oklahoma
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Pfizer
Investigators
Principal Investigator: Suman W. Rathbun, M.D. University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
  More Information

Responsible Party: Suman Rathbun, Professor of Medicine, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00245856     History of Changes
Other Study ID Numbers: 10206
ORA-20020622 ( Other Identifier: University of Oklahoma Office of Research Administration )
First Submitted: October 26, 2005
First Posted: October 28, 2005
Results First Submitted: February 1, 2013
Results First Posted: February 4, 2013
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Suman Rathbun, University of Oklahoma:
Upper Extremity Deep-Vein Thrombosis
DVT
Fragmin
Deep-Vein Thrombosis
Thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action