Evidence map›Paper›PMID 39073983›Full record

ArticleAmerican journal of clinical pathology2025

TEG® 6s coagulation testing with a novel heparin neutralization cartridge: Technical validation and determination of normal reference ranges.

Jan Hartmann, Joao Dias, Alexandra Shilo, Yamini Bynagari, Brandon Garrett, Walter Jeske, Zorayr Manukyan, Karen Mkhitaryan, Dieter Adelmann, Kathirvel Subramaniam and 1 more

Abstract readValidation Study
In one paragraph

Article in American journal of clinical pathology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

11 authors.

Jan HartmannGlobal Medical Office, Haemonetics Corporation, Boston, MA, US.ORCID 0000-0003-4978-8014
Joao DiasGlobal Medical Office, Haemonetics Corporation, Boston, MA, US.
Alexandra ShiloGlobal Medical Office, Haemonetics Corporation, Boston, MA, US.
Yamini BynagariMachaon Diagnostics, Inc, Berkeley, CA, US.
Brandon GarrettMachaon Diagnostics, Inc, Berkeley, CA, US.
Walter JeskeCardiovascular Research Institute, Loyola University Chicago, Maywood, IL, US.
Zorayr ManukyanClinStatDevice, Lexington, MA, US.
Karen MkhitaryanClinStatDevice, Lexington, MA, US.
Dieter AdelmannDepartment of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA, US.
Kathirvel SubramaniamDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, US.
Tetsuro SakaiDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA, US.

Funding

Haemonetics Corporation
6 · The paper itself

Abstract

objectivesWe sought to establish normal reference ranges (NRRs) for a novel TEG 6s cartridge (TEG 6s Citrated: K, KH, RTH, FFH [Global Hemostasis]) (Haemonetics Corporation, Boston, MA, US).

methodsHealthy volunteers (≥18 years of age) included in this single-arm study provided single samples of whole blood. Primary end points included TEG parameters in the citrated kaolin (CK), CK with heparinase (CKH), RapidTEG with heparinase (CRTH), and functional fibrinogen with heparinase (CFFH) assays.

resultsEvaluable data were contributed by 164 volunteers (48.8% female; 62% White/Caucasian). The following NRRs were established: CK maximum amplitude (MA), 51.0 to 67.6 mm; CKH-MA, 51.8 to 67.9 mm; CRTH-MA, 53.0 to 68.9 mm; CFFH-MA, 15.3 to 34.4 mm; CK reaction time, 5.0 to 9.1 minutes; CKH reaction time, 4.9 to 9.4 minutes; CKH lysis 30 minutes after MA, 0% to 3.2%. Duplicate measurements demonstrated high reproducibility. CFFH-MA correlated with Clauss fibrinogen concentration (Pearson correlation coefficient, 0.74). Laboratory-based studies demonstrated maintenance of the relationship between CFFH-MA and fibrinogen up to 1344 mg/dL (hyperfibrinogenemic samples) and acceptability of heparin neutralization up to concentrations of low molecular weight and unfractionated heparin of 1.3 IU/mL and 5 IU/mL, respectively.

conclusionsThis study established NRRs for the Global Hemostasis cartridge and serves as a proof of concept for the validity of results obtained using this cartridge.

Indexed as

Blood CoagulationHeparinThrombelastographyAdultAgedBlood Coagulation TestsFemaleHealthy VolunteersHumansMaleMiddle AgedReference ValuesReproducibility of ResultsYoung AdultHeparincoagulationhematologyquality

Identifiers

PMID39073983
PMCPMC11775113

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