Enoxaparin Dosing in Obesity

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01798550
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 43.5
• Patients Per Site Per Month: 1.4

Study Details

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
• 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: Mar 1, 2013
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 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 Names: Lovenox
Active Comparator: Standard Dose (1 mg/kg) Enoxaparin 1 mg/kg (using total body weight) twice daily	Drug: Enoxaparin; Twice daily dosing; Other Names: Lovenox

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time to Therapeutic Anti-Xa Level for Both Groups [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 [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 [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 [Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Nov 27, 2012

More Information

Publications

None provided.

• 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: Feb 26, 2013
• Last Update Posted: Dec 14, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology, Emory University: Enoxaparin dosing; Obesity
• Additional relevant MeSH terms: Obesity; Enoxaparin

Study Results

Participant Flow

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Period Title: Overall Study
STARTED	30	32
COMPLETED	28	26
NOT COMPLETED	2	6

Baseline Characteristics

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)	Total
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Total of all reporting groups
Overall Participants	30	32	62
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55	56	56
Sex: Female, Male (Count of Participants)
Female	12 40%	18 56.3%	30 48.4%
Male	18 60%	14 43.8%	32 51.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	27 90%	27 84.4%	54 87.1%
White	3 10%	5 15.6%	8 12.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	30 100%	32 100%	62 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Measure Participants	28	26
Count of Participants [Participants]	25 83.3%	20 62.5%

2. Secondary Outcome

Title	Time to Therapeutic Anti-Xa Level for Both Groups
Description	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.
Time Frame	Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Measure Participants	28	26
Median (Inter-Quartile Range) [hours]	28.6	31.9

3. Other Pre-specified Outcome

Title	Median Steady State Anti-Xa Levels
Description	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.
Time Frame	Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Measure Participants	28	26
Median (Inter-Quartile Range) [IU/mL]	0.8	0.86

4. Other Pre-specified Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Measure Participants	28	26
Count of Participants [Participants]	3 10%	6 18.8%

5. Other Pre-specified Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Dose (0.8 mg/kg)	Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Measure Participants	28	26
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	3 years, duration of the study
Arm/Group Title	Reduced Dose (0.8 mg/kg)		Standard Dose (1 mg/kg)
Arm/Group Description	Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing		Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
All Cause Mortality
	Reduced Dose (0.8 mg/kg)		Standard Dose (1 mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)
Serious Adverse Events
	Reduced Dose (0.8 mg/kg)		Standard Dose (1 mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Reduced Dose (0.8 mg/kg)		Standard Dose (1 mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.