Prophylactic Use of Enoxaparin in Morbidly Obese Adolescents During Bariatric Surgery

NCT01587781 | Completed DMC

• 1 other identifier: 1824
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about a drug called enoxaparin which is used to prevent or treat blood clots. There are no studies about the use of this drug in obese adolescents and yet the investigators use it to prevent clots when they have surgery at Children's National for weight loss. The investigators hypothesis is that the obesity leads to increased kidney size and faster drug clearance. Therefore the investigators think they might be underdosing these adolescents. This study will check the drug levels at different points after the drug dose to see whether the investigators are achieving the expected levels for prevention of clots.

Conditions

Obesity

Keywords

Pharmacokinetics of enoxaparin

Outcome Measures

Primary Outcomes (1)

• To find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents after the use of this drug as prophylaxis during bariatric surgery

  This study is non-interventional and the potential risks associated with the "study" are none. Enoxaparin will be administered as standard of care.

  In our study participants, Factor-X a level will be measured at times: 0, 1, 2, 4, 6, and 12 hr respectively. The first IV will be placed with the patient awake and the first sample of 3 ml for factor X-a (time point 0) will occur after its placement but

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 12 patients will be enrolled. The population for this study will include both male and female adolescent patients from all ethnic backgrounds with BMI greater than or equal to 95 percentile. Each patient will receive enoxaparin SC q 12 hours. The blood samples for the study would be taken prior to the second dose.

You may qualify if:

• The research participant will be a Children's National Medical Center (CNMC) patient admitted for bariatric surgery.
• The age ranges will be between 12 and 20.
• All racial and ethnic groups will be included.
• Informed consent and assent will be obtained prior to each investigation from the patients' parents and when legally appropriate from the patient.

You may not qualify if:

• This is a non-interventional study and patients would be routinely screened for history of bleeding disorders or at risk of bleeding as a part of standard complete history and exam. As a standard, patients receiving platelet inhibitors including acetylsalicylic acid, salicylates, Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone would be closely monitored.
• Any patient with prior dosing with enoxaparin or any other anticoagulant within the past 24 hours would be excluded.

Sponsors & Collaborators

• Janelle Vaughns: lead

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Mushtaq A, Vaughns JD, Ziesenitz VC, Nadler EP, van den Anker JN. Use of Enoxaparin in Obese Adolescents During Bariatric Surgery--a Pilot Study. Obes Surg. 2015 Oct;25(10):1869-74. doi: 10.1007/s11695-015-1630-x.

  PMID: 25716128 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Janelle Vaughns, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)