Recommendations for standardized risk factor definitions in pediatric hospital‐acquired venous thromboembolism to inform future prevention trials: communication from the SSC of the ISTH

Branchford, Brian R.; Mahajerin, Arash; Raffini, Leslie; Chalmers, Elizabeth; Ommen, C. Heleen van; Chan, Anthony; Goldenberg, Neil A.

doi:10.1111/jth.13848

Cited by 23 publications

(36 citation statements)

References 34 publications

(38 reference statements)

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“…CVC included un‐tunneled, tunneled, and peripherally inserted catheters. Bacteremia or systemic infection was defined as a positive culture, viral assay, imaging study, or need for systemic antibiotics . Immobilization was defined as a Braden Q mobility score of 1 or 2 .…”

Section: Methodsmentioning

confidence: 99%

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Comparative validation study of risk assessment models for pediatric hospital‐acquired venous thromboembolism

Mahajerin

Jaffray

Branchford

et al. 2020

Journal of Thrombosis and Haemostasis

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Background Risk assessment models (RAMs) have been developed to identify children at high risk of hospital‐acquired venous thromboembolism (HA‐VTE). None have been externally validated nor compared. Objectives The objective was to compare performance of these RAMs by externally validating them using the Children's Hospital‐Acquired Thrombosis (CHAT) Registry, ie, a multicenter database of children with radiographic‐confirmed HA‐VTE and corresponding controls. Patients/Methods Risk assessment models were included if the full logistic regression equation was available and all RAM variables were collected in the CHAT Registry. A random sample of 200 cases and 200 controls was selected. The performance of the RAMs was assessed for discrimination using area under the receiver operating characteristic curves (AUROC), and calibration using plots, slopes, and intercepts, and the Hosmer‐Lemeshow test. Results Three RAMs were included. Each had excellent discrimination with AUROC ≥ 0.85. However, calibration was generally poor, with calibration slopes significantly different from 1 (0.71, P < .001; 1.44, P = .002; 0.68, P < .001), intercepts significantly different from 0 (−1.64, P < .001; −0.62, P < .001; 0.78, P < .001), and Hosmer‐Lemeshow test P < .001 for each. Exceptions included the Arlikar et al and Atchison et al RAMs for pediatric HA‐VTE in non‐intensive care unit (ICU) patients and ICU patients, respectively, despite derivation from ICU and non‐ICU patients, respectively. In these subpopulations, both showed excellent discrimination and good calibration. Conclusion Given the lack of adequate calibration for evaluated RAMs, further investigation and refinement of RAMs for pediatric HA‐VTE is needed prior to application of a RAM in a clinical setting or risk‐stratified clinical trial of primary thromboprophylaxis against HA‐VTE in children.

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Section: Methodsmentioning

confidence: 99%

“…RAMs not evaluated in present study Immobilization was defined as a Braden Q mobility score of 1 or 2. 12,13 Oral contraceptives were included if they contained estrogen.…”

Section: Rams Evaluated In Present Studymentioning

confidence: 99%

Comparative validation study of risk assessment models for pediatric hospital‐acquired venous thromboembolism

Mahajerin

Jaffray

Branchford

et al. 2020

Journal of Thrombosis and Haemostasis

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“…Through an extensive chart review, we collected clinical information to document the variety of potential risk factors associated with VTE occurrence. Significant immobility, defined as a limitation in independent, purposeful physical movement of the body or of one or more extremities from baseline for >48 h, was noted. Presence of inflammation and chronic VTE risk factors, such as inflammatory bowel disease, nephrotic syndrome, autoimmune disorders, cystic fibrosis, obesity, and medications associated with VTE, was noted.…”

Section: Methodsmentioning

confidence: 99%

Promising biomarkers for the prediction of catheter‐related venous thromboembolism in hospitalized children: An exploratory study

Nossair

Mahajerin

Hoang

et al. 2019

Pediatric Blood & Cancer

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Background: Pediatric venous thromboembolism (VTE) has increased over the past 10 years, with central venous catheters (CVC) being the strongest risk factor. Current tools are not sufficient to predict VTE risk. The utility of biomarkers in predicting CVC-related VTE has been minimally explored. Our objective is to determine the utility of microparticles (MPs), factor VIII (FVIII) activity, and thrombin generation (TG) in prospectively predicting VTE occurrence in hospitalized children with CVCs. Procedure:In this nested case-control pilot study, consecutive hospitalized children needing CVC placement (1 month to 21 years) were enrolled. Venous samples were collected prior to or within 24 h of CVC placement. MPs were measured using factor Xa initiated clot-based assay. FVIII was measured using a one-stage clot-based assay. TG was measured using calibrated automated thrombogram.Results: There were three CVC-related VTE events (7%) in our cohort of 42 subjects. Xa clotting time (XaCT) ratio was lower (0.68 ± 0.07 vs 0.95 ± 0.21, P = .4), while FVIII (461 ± 120 vs 267 ± 130, P = .02), peak thrombin (418 ± 89 vs 211 ± 101, P = .001), endogenous thrombin potential (ETP) (1828 ± 485 vs 1282 ± 394, P = .03), and velocity index (VI) (182 ± 28 vs 75 ± 53, P = .001) were higher in subjects with CVC-related VTE compared to those without CVC-related VTE. Sensitivity/specificity analysis revealed optimal cutoff values for XaCT ratio (0.75), FVIII (370), ETP (1680), peak (315), and VI (130), with receiver operating characteristic area under the curve values >0.9.Conclusion: MPs, FVIII, and TG can potentially predict pediatric CVC-related VTE in a prospective fashion. Stratification according to VTE risk may aid in guiding preventative efforts in future studies.

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“…Table lists relevant risk factors, many of which (CVC, infection, length of stay, etc.) are described further in the recent ISTH Pediatric SSC position paper from the VTE Prevention Working Group and the associated meta‐analysis of the literature for HA‐VTE risk factors .…”

Section: Which Risk Groups Of Children Should Receive Thromboprophylamentioning

confidence: 99%

“…*Risk factors identified by a recent meta‐analysis of the pediatric healthcare‐associated VTE literature . †Risk factors defined in a recent publication from the ISTH Pediatric SSC .…”

Section: Which Risk Groups Of Children Should Receive Thromboprophylamentioning

confidence: 99%

Anticoagulant prophylaxis and therapy in children: current challenges and emerging issues

Newall

Branchford

Male

2018

Journal of Thrombosis and Haemostasis

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This review is aimed at describing the unique challenges of anticoagulant prophylaxis and treatment in children, and highlighting areas for research for improving clinical outcomes of children with thromboembolic disease. The evidence presented demonstrates the challenges of advancing the evidence base informing optimal management of thromboembolic disease in children. Recent observational studies have identified risk factors for venous thromboembolism in children, but there are few interventional studies assessing the benefit-risk balance of using thromboprophylaxis in risk-stratified clinical subgroups. A risk level-based framework is proposed for administering mechanical and pharmacological thromboprophylaxis. More research is required to refine the assignment of risk levels. The anticoagulants currently used predominantly in children are unfractionated heparin, low molecular weight heparin, and vitamin K antagonists. There is a paucity of robust evidence on the age-specific pharmacology of these agents, and their efficacy and safety for prevention and treatment of thrombosis in children. The available literature is heterogeneous, reflecting age-specific differences, and the various clinical settings for anticoagulation in children. Monitoring assays and target ranges are not well established. Nevertheless, weight-based dosing appears to achieve acceptable outcomes in most indications. Given the limitations of the classical anticoagulants for children, there is great interest in the direct oral anticoagulants (DOACs), whose properties appear to be particularly suitable for children. All DOACs currently approved for adults have Pediatric Investigation Plans ongoing or planned. These are generating age-specific formulations and systematic dosing information. The ongoing pediatric studies still have to establish whether DOACs have a positive benefit-risk balance in the various pediatric indications and age groups.

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Recommendations for standardized risk factor definitions in pediatric hospital‐acquired venous thromboembolism to inform future prevention trials: communication from the SSC of the ISTH

Cited by 23 publications

References 34 publications

Comparative validation study of risk assessment models for pediatric hospital‐acquired venous thromboembolism

Comparative validation study of risk assessment models for pediatric hospital‐acquired venous thromboembolism

Promising biomarkers for the prediction of catheter‐related venous thromboembolism in hospitalized children: An exploratory study

Anticoagulant prophylaxis and therapy in children: current challenges and emerging issues

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