Enoxaparin Dosing in Obesity

• 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: Emory University
• Information provided by (Responsible Party): Christine Kempton, MD, MSc, Emory University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Georgia

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: Christine L Kempton, MD, MSc; Emory University

  Study Documents (Full-Text)

Documents provided by Christine Kempton, MD, MSc, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] November 27, 2012

More Information

• 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
• 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

• 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:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Enoxaparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action