Enoxaparin Dosing in Obesity

NCT01798550 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00063210
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Enoxaparin dosing; Obesity

Outcome Measures

Primary Outcomes (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 Outcomes (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

Other Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Reduced Dose (0.8 mg/kg)

EXPERIMENTAL

Enoxaparin 0.8 mg/kg (using total body weight) twice daily

Drug: Enoxaparin

Standard Dose (1 mg/kg)

ACTIVE COMPARATOR

Enoxaparin 1 mg/kg (using total body weight) twice daily

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Twice daily dosing

Also known as: Lovenox

Reduced Dose (0.8 mg/kg); Standard Dose (1 mg/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned treating with twice daily enoxaparin
• BMI \>= 40 kg/m2

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Christine Kempton MD, MSc
• Organization: Emory University

ckempto@emory.edu

404-778-1900

Study Officials

• Christine L Kempton, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 15, 2016
• Last Updated: December 14, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Locations

US (1)