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Published on: June 4, 2020
Pediatric Thromboelastograph 6s and Laboratory Coagulation Reference Values
Katie M Moynihan1,2,3,4, Kerry Johnson3,5, Mark Rane6
1From the Department of Cardiology, Division of Cardiovascular Critical Care, Boston Children's Hospital, Massachusetts (Moynihan).
Insights
This study established new pediatric reference intervals (RIs) for Thromboelastograph 6s (TEG 6s) and coagulation tests. These age-specific RIs improve the accuracy of interpreting pediatric coagulation results.
Area of Science:
- Pediatric Coagulation Science
- Clinical Pathology
- Hemostasis Analysis
Background:
- Accurate interpretation of coagulation tests relies on specific reference intervals (RIs).
- Current TEG 6s RIs are based on adult samples, potentially leading to inaccuracies in pediatric patients.
- Coagulation assay results can differ based on patient demographics, reagents, and analyzers.
Purpose of the Study:
- To establish reagent and analyzer-specific pediatric RIs for the TEG 6s Hemostasis Analyzer.
- To develop pediatric RIs for key coagulation parameters.
- To address the lack of age-specific reference ranges in pediatric hemostasis testing.
Main Methods:
- Prospective observational study of 254 healthy children undergoing general anesthesia.
- Collected venous blood samples for TEG 6s assays (Kaolin, Kaolin-Heparinase, Rapid, Functional Fibrinogen) and standard coagulation tests (aPTT, PT, TT, Echis, Antithrombin, Fibrinogen).
- Generated pediatric RIs using discrete age groups and model-based quantile regression, analyzing age and sex influences.
Main Results:
- Clinically significant variations were observed between different reagents for prothrombin time (PT) and activated partial thromboplastin time (aPTT) assays.
- Reagent and analyzer-specific pediatric RIs were successfully generated for TEG 6s and coagulation parameters using data from 254 children.
- Both discrete and model-based RIs demonstrated age-dependent variations across all tested coagulation parameters and TEG 6s variables.
Conclusions:
- This study reports the first reagent-analyzer specific pediatric RIs for TEG 6s and coagulation parameters.
- The observed variations underscore the necessity for laboratory-specific RIs, particularly in pediatric populations.
- The developed RIs enhance the accuracy of clinical result interpretation and highlight the advantages of model-based RI approaches.
Context.—:
Specific reference intervals (RIs) facilitate accurate interpretation of results. Coagulation assay results may vary by demographics and also between reagents and analyzers used. Current Thromboelastograph 6s (TEG 6s) Hemostasis Analyzer RIs were generated from adult samples.
Objective.—:
To generate reagent analyzer-specific pediatric RIs for TEG 6s and coagulation parameters.
Design.—:
A prospective, observational, single-center study of healthy children undergoing general anesthesia (January 3, 2017 to January 3, 2019). Venous blood samples were obtained for TEG 6s (Kaolin, Kaolin-Heparinase, Rapid and Functional Fibrinogen assays) and coagulation parameters (activated partial thromboplastin time, prothrombin time, thrombin clotting time, Echis time, antithrombin activity, and fibrinogen concentration using Instrumentation Laboratory ACL-TOP analyzers). Differences between activated partial thromboplastin time and prothrombin time reagents were investigated using mixed-effects regression, comparing maximum coefficients-of-variation with assay-specific allowable variation. RIs (lower/upper limits 2.5th of 97.5th percentiles) were generated using the following 2 methods: within discrete age-groups (neonates [<1 month], infants [1 month-1 year], young children [1-5 years], older children [6-10 years], and adolescents [11-16 years]), and modeled as functions of age and/or sex using quantile regression, including significant fractional polynomial and interaction terms.
Results.—:
Variation between prothrombin time and activated partial thromboplastin time assays using different reagents was clinically significant. Reagent-analyzer specific pediatric RIs were generated using data from 254 children. Discrete and model-based RIs varied by age for all coagulation parameters and TEG 6s variables in all assays.
Conclusions.—:
We report reagent-analyzer specific pediatric RIs for TEG 6s and coagulation parameters. Observed variation reinforces recommendations for laboratory-specific RIs. These findings improve accuracy of interpretation of clinical results, provide a foundation for comparison and validation of tests in pathology, and illustrate feasibility and advantages of model-based RI approaches.
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