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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:
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
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Keywords provided by University of Utah:
Obesity
venous thrombosis
Anticoagulants

Additional relevant MeSH terms:
Obesity
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Thromboembolism
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013