Enoxaparin Dosing in Obesity
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/16/2017 |
Start Date: | March 2013 |
End Date: | October 15, 2016 |
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.
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.
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
We found this trial at
1
site
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Marjorie Curry, PharmD
Phone: 404-616-5860
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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