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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Deep-Vein Thrombosis
Interventions: Drug: Dalteparin sodium injection
Drug: Warfarin

  Participant Flow

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
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 

Period 2:   Period Two
    Dalteparin + Warfarin   Dalteparin Only
STARTED   0   39 
COMPLETED   0   38 
Withdrawal by Subject                0                1 

  Baseline Characteristics

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

Baseline Measures
   All DVT Treated Patients 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   56 
>=65 years   11 
[Units: Years]
Mean (Standard Deviation)
 52  (30) 
[Units: Participants]
Female   36 
Male   31 
Region of Enrollment 
[Units: Participants]
United States   67 

  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

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

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

Responsible Party: Suman Rathbun, University of Oklahoma Identifier: NCT00245856     History of Changes
Other Study ID Numbers: 10206
ORA-20020622 ( Other Identifier: University of Oklahoma Office of Research Administration )
First Submitted: October 26, 2005
First Posted: October 28, 2005
Results First Submitted: February 1, 2013
Results First Posted: February 4, 2013
Last Update Posted: February 21, 2013