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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
Enrollment 28

Recruitment Details 28 patients met eligibility criteria and completed the protocol enrolled from the University of Utah Hospital Inpatient Medical Service
Pre-assignment Details  
Arm/Group Title Enoxaparin 0.5mg/kg Once Daily
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Enoxaparin 0.5mg/kg Once Daily
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  82.1%
>=65 years
5
  17.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
54  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
13
  46.4%
Male
15
  53.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Peak Low Molecular Weight Heparin Anti-Xa Activity Level.
Hide Description The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL
Time Frame 4 - 6 hours after enoxaparin dosing on Day 1 and Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enoxaparin 0.5mg/kg Once Daily
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: IU/mL
0.25  (0.11)
2.Secondary Outcome
Title Clinically Relevant Bleeding Events
Hide Description Clinically Relevant Bleeding is defined as fatal bleeding, symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, or bleeding requiring intervention
Time Frame Participants were followed for the duration of hospital stay, an average of 5 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enoxaparin 0.5mg/kg Once Daily
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Events
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enoxaparin 0.5mg/kg Once Daily
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Enoxaparin 0.5mg/kg Once Daily
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enoxaparin 0.5mg/kg Once Daily
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enoxaparin 0.5mg/kg Once Daily
Affected / at Risk (%)
Total   0/28 (0.00%) 
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.
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
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