Clinical trial NCT01798550: Enoxaparin Dosing in Obesity
Official title: Evaluation of Enoxaparin Dosing in Hospitalized Morbidly Obese Patients at an Academic Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Enoxaparin dosing
Obesity
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group
timeFrame: 3-5 hours after at least 3rd dose
Secondary outcomes:
measure: Time to Therapeutic Anti-Xa Level for Both Groups
timeFrame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
Other outcomes:
measure: Median Steady State Anti-Xa Levels
timeFrame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
measure: Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level
timeFrame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
measure: Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level
timeFrame: Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Christine L Kempton, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: