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Multicenter in vitro thromboelastography and thromboelastometry standardization


Goggs, Robert; Borrelli, Antonio; Brainard, Benjamin M; Chan, Daniel L; de Laforcade, Armelle; Goy-Thollot, Isabelle; Jandrey, Karl E; Kristensen, Annemarie T; Kutter, Annette P N; Marschner, Clara B; Rannou, Benoît; Sigrist, Nadja; Wagg, Catherine (2018). Multicenter in vitro thromboelastography and thromboelastometry standardization. Journal of Veterinary Emergency and Critical Care:Epub ahead of print.

Abstract

OBJECTIVE: To establish and compare the repeatability and reproducibility of activated thromboelastography (TEG) and thromboelastometry (ROTEM) assays.
DESIGN: Multicenter in vitro test standardization.
SETTING: Veterinary academic centers.
ANIMALS: Test samples were obtained from normal, healthy dogs. Sixty identical 5 mL aliquots of canine platelet-rich plasma collected by apheresis, frozen in 6% dimethyl sulfoxide, were tested initially. Sixty identical 6 mL aliquots of canine fresh frozen plasma with admixed cryoprecipitate were subsequently evaluated.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: Frozen study samples, quality controls, reagents, and consumables were distributed to participating centers (7 TEG and 3 ROTEM). TEG centers analyzed study samples with kaolin and tissue factor activated assays; ROTEM centers ran proprietary ellagic acid activated and tissue factor activated assays. All machines underwent quality control prior to sample analysis. Within- and between-center coefficients of variation (CVs) were calculated and compared using Mann-Whitney tests and calculation of intraclass correlation coefficients. Within and between centers, individual parameters for both TEG and ROTEM assays were comparable. Both within-center and between-center CVs varied markedly (0.7-120.5% and 1.4-116.5%, respectively) with assay type, instrument, and parameter. CVs for equivalent parameters were not significantly different between the 2 platforms. Intraclass correlation coefficients suggested moderate agreement between centers. In general, individual parameter CVs for platelet-rich plasma samples were lower in TEG centers, while CVs for canine fresh frozen plasma with admixed cryoprecipitate samples were lower in ROTEM centers.
CONCLUSIONS: More variation within and between centers was identified than anticipated, but some parameters such as alpha angle were repeatable and reproducible. Sample types for future multicenter standardization efforts will require further optimization and may need to be adapted separately to each platform. Individual centers using viscoelastic tests for evaluation and management of clinical patients should take steps to minimize preanalytical and analytical sources of variation.

Abstract

OBJECTIVE: To establish and compare the repeatability and reproducibility of activated thromboelastography (TEG) and thromboelastometry (ROTEM) assays.
DESIGN: Multicenter in vitro test standardization.
SETTING: Veterinary academic centers.
ANIMALS: Test samples were obtained from normal, healthy dogs. Sixty identical 5 mL aliquots of canine platelet-rich plasma collected by apheresis, frozen in 6% dimethyl sulfoxide, were tested initially. Sixty identical 6 mL aliquots of canine fresh frozen plasma with admixed cryoprecipitate were subsequently evaluated.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: Frozen study samples, quality controls, reagents, and consumables were distributed to participating centers (7 TEG and 3 ROTEM). TEG centers analyzed study samples with kaolin and tissue factor activated assays; ROTEM centers ran proprietary ellagic acid activated and tissue factor activated assays. All machines underwent quality control prior to sample analysis. Within- and between-center coefficients of variation (CVs) were calculated and compared using Mann-Whitney tests and calculation of intraclass correlation coefficients. Within and between centers, individual parameters for both TEG and ROTEM assays were comparable. Both within-center and between-center CVs varied markedly (0.7-120.5% and 1.4-116.5%, respectively) with assay type, instrument, and parameter. CVs for equivalent parameters were not significantly different between the 2 platforms. Intraclass correlation coefficients suggested moderate agreement between centers. In general, individual parameter CVs for platelet-rich plasma samples were lower in TEG centers, while CVs for canine fresh frozen plasma with admixed cryoprecipitate samples were lower in ROTEM centers.
CONCLUSIONS: More variation within and between centers was identified than anticipated, but some parameters such as alpha angle were repeatable and reproducible. Sample types for future multicenter standardization efforts will require further optimization and may need to be adapted separately to each platform. Individual centers using viscoelastic tests for evaluation and management of clinical patients should take steps to minimize preanalytical and analytical sources of variation.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:05 Vetsuisse Faculty > Veterinary Clinic > Department of Small Animals
05 Vetsuisse Faculty > Veterinary Clinic > Department of Clinical Diagnostics and Services
Dewey Decimal Classification:570 Life sciences; biology
630 Agriculture
Uncontrolled Keywords:canine; dog; repeatability; reproducibility; thromboelastography; thromboelastometry
Language:English
Date:2018
Deposited On:06 Apr 2018 10:27
Last Modified:13 Apr 2018 11:55
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:1476-4431
OA Status:Closed
Publisher DOI:https://doi.org/10.1111/vec.12710
PubMed ID:29604163

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