Treatment of Upper Extremity Deep-Vein Thrombosis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00245856
First received: October 26, 2005
Last updated: February 15, 2013
Last verified: February 2013

October 26, 2005
February 15, 2013
September 2002
March 2009   (final data collection date for primary outcome measure)
  • Percentage of Participants That Died at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • New Venous Thromboembolism at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    New DVT or PE at 3 months confirmed by diagnostic testing
- To document the long-term outcome (prognosis) of patients diagnosed with upper extremity DVT who are treated with Fragmin for 3 months.
Complete list of historical versions of study NCT00245856 on ClinicalTrials.gov Archive Site
Bleeding Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Total major bleeding rate
Not Provided
Not Provided
Not Provided
 
Treatment of Upper Extremity Deep-Vein Thrombosis
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Deep-Vein Thrombosis
  • 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
Experimental: Treatment of Upper Extremity DVT
Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
Interventions:
  • Drug: Dalteparin sodium injection
  • Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2011
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245856
10206, ORA-20020622
Not Provided
Suman Rathbun, University of Oklahoma
University of Oklahoma
Pfizer
Principal Investigator: Suman W. Rathbun, M.D. University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
University of Oklahoma
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP