Enoxaparin Dosing in Obesity

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Dose (0.8 mg/kg); Enoxaparin 0.8 mg/kg (using total body weight) twice daily	Drug: Enoxaparin; Twice daily dosing; Other Names: Lovenox
Active Comparator: Standard Dose (1 mg/kg); Enoxaparin 1 mg/kg (using total body weight) twice daily	Drug: Enoxaparin; Twice daily dosing; Other Names: Lovenox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group	3-5 hours after at least 3rd dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Therapeutic Anti-Xa Level for Both Groups	Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.	Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Steady State Anti-Xa Levels	The goal anti-Xa peak level range was defined as 0.5 - 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.	Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level		Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level		Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Christine L Kempton, MD, MSc, Emory University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 15, 2016

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Enoxaparin dosing
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: IRB00063210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No