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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
Results First Received: February 1, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Deep-Vein Thrombosis
Interventions: Drug: Dalteparin sodium injection
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.

Reporting Groups
  Description
Dalteparin + Warfarin

200 units per kg with transition Warfarin titrated to INR 2-3

This arm was completed and new treatment regimen was substituted for the remainder of the study.

Dalteparin Only 200 units/kg for one month At month one, dosage reduction based on weight

Participant Flow for 2 periods

Period 1:   Period One
    Dalteparin + Warfarin     Dalteparin Only  
STARTED     28     0  
COMPLETED     28     0  
NOT COMPLETED     0     0  

Period 2:   Period Two
    Dalteparin + Warfarin     Dalteparin Only  
STARTED     0     39  
COMPLETED     0     38  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All DVT Treated Patients Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months

Baseline Measures
    All DVT Treated Patients  
Number of Participants  
[units: participants]
  67  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     56  
>=65 years     11  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 30  
Gender  
[units: participants]
 
Female     36  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     67  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants That Died at 3 Months   [ Time Frame: 3 months ]

2.  Primary:   New Venous Thromboembolism at 3 Months   [ Time Frame: 3 months ]

3.  Secondary:   Bleeding Events   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Suman Rathbun MD
Organization: University of Oklahoma Health Sciences Center
phone: 4052714742 ext 44773
e-mail: suman-rathbun@ouhsc.edu


No publications provided


Responsible Party: Suman Rathbun, 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