Treatment of Upper Extremity Deep-Vein Thrombosis

NCT00245856

Last updated date
Study Location
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Deep-Vein Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Deep-Vein ThrombosisTreatment of Upper Extremity Deep-Vein Thrombosis
NCT00245856
  1. Oklahoma City, Oklahoma
  2. Oklahoma City, Oklahoma
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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