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Enoxaparin Dosing in Obesity

NCT ID: NCT01798550

Last Updated: 2017-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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Enoxaparin dosing Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced Dose (0.8 mg/kg)

Enoxaparin 0.8 mg/kg (using total body weight) twice daily

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

Twice daily dosing

Standard Dose (1 mg/kg)

Enoxaparin 1 mg/kg (using total body weight) twice daily

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Twice daily dosing

Interventions

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Enoxaparin

Twice daily dosing

Intervention Type DRUG

Other Intervention Names

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Lovenox

Eligibility Criteria

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Inclusion Criteria

* Planned treating with twice daily enoxaparin
* BMI \>= 40 kg/m2

Exclusion Criteria

* \< 18 years of age
* CrCl \< 30 ml/min
* Pregnancy
* Prisoner
* Active bleeding
* Already received 3 consecutive doses of enoxaparin
* Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Christine Kempton, MD, MSc

Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine L Kempton, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00063210

Identifier Type: -

Identifier Source: org_study_id