Prophylactic Use of Enoxaparin in Morbidly Obese Adolescents During Bariatric Surgery
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prophylactic Use of Enoxaparin in Morbidly Obese Adolescents During Bariatric Surgery|
- 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]This study is non-interventional and the potential risks associated with the "study" are none. Enoxaparin will be administered as standard of care.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Enoxaparin is the drug of choice for prevention and treatment of venous thromboembolism (VTE) in children and adults. A major concern with any antithrombotic therapy is an increased risk of hemorrhage. There are not many concrete data published for enoxaparin use in children and adolescents, and absolutely no guidance is available for (morbidly) obese children and adolescents as they are not included in clinical trials during the clinical phases of drug development. Physicians often find themselves puzzled when selecting a dose for obese children. This study aims to find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents that will result in a safe and effective use of this drug as prophylaxis during bariatric surgery.
The optimum therapeutic/preventive dose of a drug depends on its pharmacokinetic and pharmacodynamic properties. Both these processes can be affected by body composition and the physiological changes that occur in obese children. Obesity not only increases the total fat amount, but also the lean body mass. However, the percentage of fat tissue increases more than the lean body mass. Obesity as a disease state is also associated with changes in plasma protein constituents, decreases in tissue perfusion; and increases in adipose tissue mass, lean body mass, cardiac output, and splanchnic blood flow, as compared with normal-weight individuals.
High BMI is believed be an independent risk factor for VTE. Therefore, obese adolescents are also being prescribed prophylactic doses of enoxaparin in situations where there is risk of VTE. The 2008 recommended guidelines by the American College of Chest Physicians does not mention any type of dosing considerations of anticoagulants in obese children. However, it states that higher than usual doses be used in adult patients undergoing bariatric surgery. The use of enoxaparin is not approved for children but is being used widely for the prophylaxis and treatment of VTE in a wide variety of settings in children of all age groups. There are very limited number of studies that involve enoxaparin use in children. Out of these most of the data are available for the use of enoxaparin for the treatment of VTE and not prophylaxis of VTE.
Studies have shown several age related physiologic differences between pediatric and adult patients. Neonates exhibit an accelerated clearance rate and a larger volume of distribution as compared with adults. Children treated for malignancy required higher doses compared to adults. Pharmacokinetic/pharmacodynamic studies that have included children do not provide specific data on different age groups. Further more, the sample size is very small and mostly involve patients that were treated for VTE or thrombophilia. There is no information specifying dosing for prophylactic therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587781
|Contact: Elaine Williams, PhD, RNfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Janelle Vaughns, MD 202-476-8776 JVaughns@cnmc.org|
|Contact: Elaine Williams, PhD, RN 202-476-2245 email@example.com|
|Principal Investigator: John van den Anker, MD PhD|
|Principal Investigator: Janelle Vaughns, MD|
|Sub-Investigator: Evan Nadler, MD|
|Sub-Investigator: Elaine Williams, PhD, RN|
|Sub-Investigator: Victoria Ziesenitz, MD|