Venous Thromboembolism Prophylaxis in Adolescent Patients with Sickle Cell Disease: A Multicenter Cohort Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 28-29
Author(s):  
Jennifer G. Davila ◽  
Sarah H. O'Brien ◽  
Joseph R Stanek

Background: Evolving pediatric data, including case reports, case series, and combined adult and adolescent cohort studies, suggest an increased prevalence of venous thromboembolism (VTE) in children with Sickle Cell Disease (SCD) who undergo central venous catheter (CVC) placement (Ko RH and Thornburg C, Front Pediatr, 2017). Additionally, VTE has been shown to affect patients with SCD at a younger age compared to African-American controls (Stein PD, et al, Am J Med, 2006). Anecdotally, pediatric hematologists acknowledge the VTE risk in pediatric patients with SCD and have been using thromboprophylaxis in their patients despite the lack of standardized guidelines. The goal of this retrospective cohort study is to assess the utilization of pharmacologic and non-pharmacologic thromboprophylaxis in adolescent patients with SCD using a large pediatric database. Methods: The data source for this multicenter cohort study was the Pediatric Health Information Systems (PHIS), an administrative database that contains clinical and resource utilization data for inpatient, ambulatory surgery, emergency department, and observation unit patient encounters for 49 freestanding children's hospitals in the US. ICD-9-CM and ICD-10-CM codes were used to identify subjects, including SCD genotype (SS, SC and SB0 thal) and other comorbidities (acute chest syndrome, vaso-occlusive crisis, osteomyelitis, and bacteremia). We included subjects, aged 13-21 years, admitted to any PHIS hospital between 01/01/2010 - 12/31/2019. Subjects with a history of VTE were excluded. Supply billing codes were used to identify CVC placement and mechanical prophylaxis. Pharmaceutical billing codes were used to identify anticoagulant use. Results: 6,903 unique patients (3,147 male) met inclusion criteria with a median age of 17.2 years (13.0-21.9 years). These patients comprised a total of 33,298 admissions, with 2,434 (7.3%) admissions identified as receiving pharmacologic or mechanical prophylaxis (Table 1). 4.3% of the total admissions received mechanical prophylaxis and 3.3% received pharmacologic prophylaxis. Enoxaparin was the most commonly used anticoagulant, utilized in 91.3% of admissions in which pharmacologic anticoagulation was prescribed. The use of thromboprophylaxis was noted to increase over the study period, with significant increases observed in both pharmacologic and mechanical prophylaxis(p<.0001; Figure 1). The percentage of unique patients receiving thromboprophylaxis at each participating institution is shown in Figure 2. WConclusions: Use of both pharmacologic and mechanical thromboprophylaxis in hospitalized adolescent patients with SCD has increased in the last decade. However, there is variability amongst pediatric hospitals regarding the use and preferred method of thromboprophylaxis. Prospective cohort studies are needed to determine VTE risk factors in adolescents and children with SCD and the efficacy of prophylaxis regimens. These studies will help guide the development of VTE prophylaxis regimens. Disclosures Davila: ATHN: Other: Grant Funding; Spire Learning: Speakers Bureau. O'Brien:Bristol Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: The use of Direct Oral Anticoagulants and Enoxaparin in children

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 7-7 ◽  
Author(s):  
Riten Kumar ◽  
Joseph R Stanek ◽  
Susan E Creary ◽  
Sarah O'Brien

Abstract Background: A hypercoagulable state resulting in increased venous thrombo-embolism (VTE) has been described in adults with sickle cell disease (SCD). Similar data for children is lacking. Previously, in a single-institution, retrospective study of 414 pediatric patients with SCD followed at Nationwide Children's Hospital (NCH) between 2009 and 2015, we identified central venous catheters (CVC) as an independent risk factor for VTE [OR (± 95%CI): 10.3 (1.1-92.2)]. 12/414 (2.9%) subjects developed VTE over the course of the study1. The objective of this retrospective, multicenter cohort study was to describe risk factors associated with VTE in children with SCD across children's hospitals in the United States (US). Methods: This study was deemed to be exempt by the Institutional Review Board at NCH. Data source for this multicenter cohort study was the Pediatric Health Information Systems (PHIS), an administrative database that contains clinical and resource utilization data for inpatient, ambulatory surgery, emergency department and observation unit patient encounters for 49 free standing children's hospitals in the US. Data quality and reliability are assured through a joint effort between Children's Hospital Association and participating institutions2. ICD-9-CM codes were used to identify subjects. Eligible subjects were <21 years of age, were admitted to one of the PHIS hospitals between 01/01/2009 and 12/31/2013 and had at least 2 SCD specific ICD-9 discharge codes. VTE and comorbid conditions of interest (congenital heart disease, cancer, chronic renal disease, obesity, inflammatory bowel disease etc) were also identified using ICD-9 codes. Supply codes were used to identify CVC placement and pharmaceutical billing codes to identify oral contraceptive use. Logistic regression analysis was used to study association between unique patient characteristics and VTE. Due to the low event rate of VTE, logistic regression models were corrected using the Firth method. Variables found to be significant (p-value < 0.05) on univariate analysis were entered into a multivariable model. All data were summarized and presented using descriptive statistics. All statistical analyses were performed using SAS software, version 9.3 (SAS Institute, Cary, NC). Results: A total of 8941 unique subjects (4359 female) met inclusion criteria with a mean age (± 95%CI) of 7.28 (7.14-7.42) years. 159 subjects (96 female) developed VTE during the study period. Mean age (± 95%CI) at VTE diagnosis was 14.73 (13.84-15.63) years. No increase in VTE diagnosis was appreciated over the course of the study. On multivariable analysis, any CVC placement [OR (± 95%CI): 8.9 (6.45-12.3); p<0.0001], chronic renal disease [5.19 (1.48-18.19); p=0.01], female gender [1.59 (1.15-2.20); p=0.005), and older age at admission [1.10 (1.07-1.12); p<0.0001] were identified as risk factors associated with VTE diagnosis. Patients with SCD and VTE were more likely to be admitted to the intensive care unit (1.61 (0.99-2.62); p=0.05), though VTE diagnosis had no impact on mortality [1.49 (0.44-5.10); p=0.5]. Conclusion: Rate of VTE in children with SCD admitted to children's hospitals in the US is around 1.8%. CVC use is associated with a nearly 9-fold increased risk of VTE diagnosis. Additionally, chronic renal disease, female gender and older age at admission were also associated with VTE diagnosis. Prospective cohort studies are needed to confirm these findings and develop risk prediction models for VTE in children with SCD. Such studies will help develop and validate evidence based VTE prophylactic regimens for children with SCD. Reference: 1. Woods G, Sharma R, Creary S, et al. Venous thrombo-embolism (VTE) in children with sickle cell disease (SCD): an institutional experience. Journal of Thrombosis and Haemostasis. 2015;13:58-58. 2. Witmer CM, Lambert MP, O'Brien SH, Neunert C. Multicenter Cohort Study Comparing U.S. Management of Inpatient Pediatric Immune Thrombocytopenia to Current Treatment Guidelines. Pediatr Blood Cancer. 2016;63(7):1227-1231. Disclosures No relevant conflicts of interest to declare.


2018 ◽  
Vol 197 ◽  
pp. 186-190.e1 ◽  
Author(s):  
Gary M. Woods ◽  
Ruchika Sharma ◽  
Susan Creary ◽  
Sarah O'Brien ◽  
Joseph Stanek ◽  
...  

PEDIATRICS ◽  
2016 ◽  
Vol 137 (Supplement 3) ◽  
pp. 264A-264A
Author(s):  
Parth J. Bhatt ◽  
Dinesh Singh ◽  
Akingbola Olubenga ◽  
Devraj Chavda ◽  
Achint Patel

Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 143
Author(s):  
Julie Sommet ◽  
Enora Le Roux ◽  
Bérengère Koehl ◽  
Zinedine Haouari ◽  
Damir Mohamed ◽  
...  

Background: Many pediatric studies describe the association between biological parameters (BP) and severity of sickle cell disease (SCD) using different methods to collect or to analyze BP. This article assesses the methods used for collection and subsequent statistical analysis of BP, and how these impact prognostic results in SCD children cohort studies. Methods: Firstly, we identified the collection and statistical methods used in published SCD cohort studies. Secondly, these methods were applied to our cohort of 375 SCD children, to evaluate the association of BP with cerebral vasculopathy (CV). Results: In 16 cohort studies, BP were collected either once or several times during follow-up. The identified methods in the statistical analysis were: (1) one baseline value per patient (2) last known value; (3) mean of all values; (4) modelling of all values in a two-stage approach. Applying these four different statistical methods to our cohort, the results and interpretation of the association between BP and CV were different depending on the method used. Conclusion: The BP prognostic value depends on the chosen statistical analysis method. Appropriate statistical analyses of prognostic factors in cohort studies should be considered and should enable valuable and reproducible conclusions.


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