Dataset Information

Prophylactic Use of Enoxaparin in Adolescents During Bariatric Surgery-a Prospective Clinical Study.

ABSTRACT:

Introduction

Severe obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery.

Methods

Adolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI?2) and 60 mg SC (for a BMI???50 kg/m²) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Plasma Anti-Factor Xa (Anti-FXa) activity was used as a surrogate marker for enoxaparin pharmacokinetics.

Results

Ten female and two male obese adolescents (age range 14-19 years) had a mean BMI of 49.9 kg/m² (38.4-58 kg/m²). Four patients had a BMI of less than 50 kg/m² and received 40 mg enoxaparin, resulting in a mean dosage of 0.352?±?0.070 mg/kg body weight. Eight patients were dosed with 60 mg enoxaparin every 12 h, resulting in a mean dosage of 0.395?±?0.028 mg/kg. Peak plasma anti-FXa activity (C_max) ranged from 0.14 to 0.30 IU/mL, median C_max was 0.205 IU/mL. Median T_max was 5.67 h (range 3.78-7.52 h). Median AUC_i was 1.00 h IU/mL (range 0.42-1.67 h IU/mL). Ten out of 12 patients (83%) reached the primary endpoint with anti-FXa activity in the range for VTE prevention (0.1-0.3 IU/mL).

Conclusions

Our dosing scheme of 40 mg vs. 60 mg enoxaparin stratified according to BMI proved to be effective in reaching prophylactic anti-FXa activity in 83% of adolescent patients.

SUBMITTER: Vaughns JD

PROVIDER: S-EPMC7375856 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Prophylactic Use of Enoxaparin in Adolescents During Bariatric Surgery-a Prospective Clinical Study.

Vaughns Janelle D JD Ziesenitz Victoria C VC Williams Elaine F EF Nadler Evan P EP Mikus Gerd G van den Anker Johannes J

Obesity surgery 20200101 1

<h4>Introduction</h4>Severe obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery.<h4>Methods</h4>Adolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI < 50 kg/m<sup>2</sup>) and 60 mg SC (for a BMI ≥ 50 kg/m<sup>2</sup>) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Pla ...[more]

PMID: 31463801

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Project description:Background & aimsLittle is known about prevalence and risk factors for nutritional deficiencies in adolescents after metabolic bariatric surgery. We performed a 5-year prospective cohort study of these.MethodsAdolescents who had Roux-en-Y gastric bypass (RYGB, n = 161) or vertical sleeve gastrectomy (VSG, n = 67) were enrolled at 5 tertiary-care centers from March 2007 through February 2012. The final analysis cohort included 226 participants (161 who had RYGB and 65 who had VSG). We measured serum levels of ferritin; red blood cell folate; vitamins A, D, B1, B12; and parathyroid hormone at baseline and annually for 5 years. General linear mixed models were used to examine changes over time and identify factors associated with nutritional deficiencies.ResultsThe participants were 75% female and 72% white, with a mean age of 16.5 ± 1.6 years and mean body mass index of 52.7 ± 9.4 kg/m2 at surgery. Mean body mass index decreased 23% at 5 years, and did not differ significantly between procedures. After RYGB, but not VSG, serum concentrations of vitamin B12 significantly decreased whereas serum levels of transferrin and parathyroid hormone increased. Ferritin levels decreased significantly after both procedures. Hypo-ferritinemia was observed in 2.5% of patients before RYGB and 71% at 5 y after RYGB (P < .0001), and 11% of patients before VSG and 45% 5 y after VSG (P = .002). No significant changes in serum levels of folate or vitamins A, B1, or D were found between baseline and 5 y after either procedure. By 5 y, 59% of RYGB and 27% of VSG recipients had 2 or more nutritional deficiencies. Risk factors associated with specific deficiencies included surgery type, female sex, black race, supplementation intake, weight regain, and for females, pregnancy.ConclusionsIn a prospective study of adolescents who underwent RYGB or VSG, we observed nutritional deficiencies by 5 y after the procedures-particularly in iron and B12 after RYGB. Ongoing nutrient monitoring and supplementation are recommended for all patients, but surgery type, supplementation intake, sex, and race might affect risk. (Clinical trial registration: Adolescent Bariatrics: Assessing Health Benefits and Risk [also known as Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS)], NCT00474318.).

Dataset Information

Prophylactic Use of Enoxaparin in Adolescents During Bariatric Surgery-a Prospective Clinical Study.

Introduction

Methods

Results

Conclusions

Publications

Prophylactic Use of Enoxaparin in Adolescents During Bariatric Surgery-a Prospective Clinical Study.

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