CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
Enoxaparindrug
Likely dose
Not stated in 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/NCT01798550
NCT01798550Phase 4Completed

Evaluation of Enoxaparin Dosing in Hospitalized Morbidly Obese Patients at an Academic Medical Center

Emory University·interventional·Posted Feb 26, 2013·Updated Dec 14, 2017

In Brief

A Phase 4 clinical trial evaluating Enoxaparin for Obesity. Completed, enrolled 62 participants across 1 site.

Detailed Summary

The purpose of this study is to determine an effective enoxaparin dosing strategy in medically ill, morbidly obese patients. This study will include adult patients greater than 18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable patients such as prisoners, children, and pregnant women will not be enrolled in the study. Study participants will be contacted in person by the study personnel once inclusion criteria are met. Written informed consent will be obtained in person while hospitalized. Once the patient is consented they will be given enoxaparin and blood samples will be drawn. The data collected will be from the electronic medical record which is accessed only with a username and password so it is not publicly available. The data will be identifiable upon collection and will be kept on a password protected file on a computer in a locked office. The data will be de-identified after data analysis and only the study personnel will have access to the code that links identifiers to subjects. A HIPAA waiver will be requested to access existing data in order to identify patients for enrollment. All data will be collected in an office in the hospital. The study participants' burden will be minimal and dependent only on time of consent process since morbidly obese patients would be receiving this blood sample collection regardless of their participation in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartMar 1, 2013
Primary CompletionOct 1, 2016
Study CompletionOct 15, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.3 years ago

Interventions

Enoxaparindrug

Twice daily dosing