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Trial record 1 of 1 for:    NCT00245856
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Treatment of Upper Extremity Deep-Vein Thrombosis

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.
 
ClinicalTrials.gov Identifier: NCT00245856
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : February 4, 2013
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma

Tracking Information
First Submitted Date  ICMJE October 26, 2005
First Posted Date  ICMJE October 28, 2005
Results First Submitted Date  ICMJE February 1, 2013
Results First Posted Date  ICMJE February 4, 2013
Last Update Posted Date February 21, 2013
Study Start Date  ICMJE September 2002
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2005)
- To document the long-term outcome (prognosis) of patients diagnosed with upper extremity DVT who are treated with Fragmin for 3 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
Bleeding Events [ Time Frame: 3 months ]
Total major bleeding rate
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Upper Extremity Deep-Vein Thrombosis
Official Title  ICMJE Treatment of Upper Extremity Deep-Vein Thrombosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Deep-Vein Thrombosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2012)
67
Original Enrollment  ICMJE
 (submitted: October 26, 2005)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245856
Other Study ID Numbers  ICMJE 10206
ORA-20020622 ( Other Identifier: University of Oklahoma Office of Research Administration )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suman Rathbun, University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Suman W. Rathbun, M.D. University of Oklahoma Health Science Center, Dept of Medicine/CardioVascular section
PRS Account University of Oklahoma
Verification Date February 2013

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