CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Enoxaparin 0.5 mg/kg once dailydrug
Likely dose
Enoxaparin 0.5 mg/kg once dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00585182
NCT00585182Phase 4Completed

Venous Thromboembolism Prevention in the Morbidly Obese Medically Ill Patient: A Pharmacological Analysis of the Predictability of Prophylactic Weight-Based Enoxaparin Dosing.

University of Utah·interventional·Posted Jan 3, 2008·Updated Apr 5, 2018

In Brief

A Phase 4 clinical trial evaluating Enoxaparin 0.5 mg/kg once daily for Obesity and 2 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2008
Enrollment StartJan 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.5 years ago

Interventions

Enoxaparin 0.5 mg/kg once dailydrug

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