Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00585182
First received: December 21, 2007
Last updated: August 2, 2011
Last verified: August 2011
Results First Received: August 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Obesity
Venous Thrombosis
Anticoagulants
Intervention: Drug: Enoxaparin 0.5 mg/kg once daily

  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
28 patients met eligibility criteria and completed the protocol enrolled from the University of Utah Hospital Inpatient Medical Service

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
NA

Reporting Groups
  Description
Enoxaparin 0.5mg/kg Once Daily No text entered.

Participant Flow:   Overall Study
    Enoxaparin 0.5mg/kg Once Daily  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  



  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
Enoxaparin 0.5mg/kg Once Daily No text entered.

Baseline Measures
    Enoxaparin 0.5mg/kg Once Daily  
Number of Participants  
[units: participants]
  28  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 11  
Gender  
[units: participants]
 
Female     13  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
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1.  Primary:   Peak Low Molecular Weight Heparin Anti-Xa Activity Level.   [ Time Frame: Day 2 ]

2.  Secondary:   Clinically Relevant Bleeding   [ Time Frame: Through hospitalization ]


  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
This study was limited by a relatively small sample size, lack of long-term clinical outcome data, and the use of only a single anti-Xa level, rather than repeat measures.


  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: Dr Robert Pendleton
Organization: University of Utah
phone: 801 581 7818
e-mail: robert.pendleton@hsc.utah.edu


No publications provided


Responsible Party: Robert C Pendleton, University of Utah
ClinicalTrials.gov Identifier: NCT00585182     History of Changes
Other Study ID Numbers: 20115, Utah IRB 20115
Study First Received: December 21, 2007
Results First Received: August 2, 2011
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board