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

NCT00585182 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-04-05

Study results available
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Summary

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.

Conditions

  • Obesity
  • Venous Thrombosis
  • Anticoagulants

Interventions

DRUG

Enoxaparin 0.5 mg/kg once daily

Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.

Sponsors & Collaborators

Principal Investigators

  • Robert C Pendleton, MD · University of Utah

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585182 on ClinicalTrials.gov