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

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.
ClinicalTrials.gov Identifier: NCT00585182
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : September 5, 2011
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Utah

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Obesity
Venous Thrombosis
Anticoagulants
Intervention: Drug: Enoxaparin 0.5 mg/kg once daily

  Participant Flow

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
No text entered.

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

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 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      23  82.1% 
>=65 years      5  17.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  46.4% 
Male      15  53.6% 
Region of Enrollment 
[Units: Participants]
 
United States   28 


  Outcome Measures

1.  Primary:   Peak Low Molecular Weight Heparin Anti-Xa Activity Level.   [ Time Frame: 4 - 6 hours after enoxaparin dosing on Day 1 and Day 2 ]

2.  Secondary:   Clinically Relevant Bleeding Events   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 5 days ]


  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
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

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



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585182     History of Changes
Other Study ID Numbers: 20115
Utah IRB 20115
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: August 2, 2011
Results First Posted: September 5, 2011
Last Update Posted: April 5, 2018