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Completed

NCT Number: NCT01798550

Enoxaparin Dosing in Obesity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

Twice daily dosing

Other names: Lovenox

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2013
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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