Enoxaparin Dosing in Obesity

Study Overview
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enoxaparin dosing, Obesity