Enoxaparin Dosing in Obesity

Emory University

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01798550

IRB00063210

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Reduced Dose (0.8 mg/kg)

Experimental group

Description:

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

Treatment:

Drug: Enoxaparin

Standard Dose (1 mg/kg)

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin