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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585182
First Posted: January 3, 2008
Last Update Posted: September 5, 2011
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.
Collaborator:
Sanofi
Information provided by:
University of Utah
  Purpose
Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once daily in severely obese patients will lead to predictable blood levels.

Condition Intervention Phase
Obesity Venous Thrombosis Anticoagulants Drug: Enoxaparin 0.5 mg/kg once daily Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Venous Thromboembolism Prevention in the Morbidly Obese Medically Ill Patient: A Pharmacological Analysis of the Predictability of Prophylactic Weight-Based Enoxaparin Dosing.

Resource links provided by NLM:


Further study details as provided by University of Utah:

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


Secondary Outcome Measures:
  • Clinically Relevant Bleeding [ Time Frame: Through hospitalization ]

Enrollment: 35
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Enoxaparin 0.5 mg/kg once daily
Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
Other Name: Lovenox

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese patients (BMI>35kg/m2)>18 years of age admitted to medical service and considered at increased risk for DVT and whom pharmacological prophylaxis is being considered by treating physician.

Exclusion Criteria:

  • Pregnancy
  • Currently on alternate therapeutic anticoagulant (warfarin, heparin, LMWH)
  • Platelet count <100,000, CrCl <30ml/min, or coagulopathy
  • recent (within 14 d) stroke, trauma, or major surgical procedure
  • Active bleeding or deemed at increased bleeding risk by the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585182


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Sanofi
Investigators
Principal Investigator: Robert C Pendleton, MD University of Utah
  More Information

Responsible Party: Robert C Pendleton, 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: September 5, 2011
Last Verified: August 2011

Keywords provided by University of Utah:
Obesity
venous thrombosis
Anticoagulants

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases


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