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Enoxaparin Dosing in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798550
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : November 6, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Christine Kempton, MD, MSc, Emory University

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Enoxaparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Enoxaparin Dosing in Hospitalized Morbidly Obese Patients at an Academic Medical Center
Study Start Date : March 2013
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 15, 2016

Resource links provided by the National Library of Medicine


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 Name: Lovenox

Active Comparator: Standard Dose (1 mg/kg)
Enoxaparin 1 mg/kg (using total body weight) twice daily
Drug: Enoxaparin
Twice daily dosing
Other Name: Lovenox




Primary Outcome Measures :
  1. Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group [ Time Frame: 3-5 hours after at least 3rd dose ]

Secondary Outcome Measures :
  1. Time to Therapeutic Anti-Xa Level for Both Groups [ Time Frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days ]
    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.


Other Outcome Measures:
  1. Median Steady State Anti-Xa Levels [ Time Frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days ]
    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.

  2. Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level [ Time Frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days ]
  3. Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level [ Time Frame: Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798550


Locations
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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Christine L Kempton, MD, MSc Emory University
  Study Documents (Full-Text)

Documents provided by Christine Kempton, MD, MSc, Emory University:
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Responsible Party: Christine Kempton, MD, MSc, Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology, Emory University
ClinicalTrials.gov Identifier: NCT01798550    
Other Study ID Numbers: IRB00063210
First Posted: February 26, 2013    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: December 14, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Kempton, MD, MSc, Emory University:
Enoxaparin dosing
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action