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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Oklahoma:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Bleeding Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245856

Locations
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73117
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
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

No publications provided

Responsible Party: Suman Rathbun, Professor of Medicine, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00245856     History of Changes
Other Study ID Numbers: 10206, ORA-20020622
Study First Received: October 26, 2005
Results First Received: February 1, 2013
Last Updated: February 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Dalteparin
Heparin, Low-Molecular-Weight
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014