Authors: Adelmann, Dieter et al.
Anesthesiology, September 18, 2025. DOI: 10.1097/ALN.0000000000005759
This multicenter observational study validated the newly FDA-cleared TEG® 6s Global Hemostasis – Heparin Neutralization cartridge for use in patients receiving unfractionated heparin during cardiovascular surgeries and procedures. The cartridge integrates heparinase to neutralize heparin’s anticoagulant effects, enabling accurate viscoelastic testing under heparinized conditions—a known limitation of traditional thromboelastography systems.
A total of 543 samples were obtained from 185 adult patients (113 undergoing cardiopulmonary bypass and 72 undergoing cardiovascular procedures without bypass). Blood samples were drawn before heparin administration, after heparinization, and following reversal or completion of the procedure. Key assays on the Heparin Neutralization cartridge—kaolin, kaolin with heparinase, RapidTEG™ with heparinase, and functional fibrinogen with heparinase—were compared with corresponding assays on the clinically validated TEG® 6s Citrated Multichannel cartridge and with Clauss plasma fibrinogen levels.
Results demonstrated excellent agreement between cartridges, with Deming regression slopes near 1.0 and Pearson correlation coefficients ranging from 0.79 to 0.96. The functional fibrinogen with heparinase assay correlated moderately with plasma fibrinogen (Spearman r = 0.68). Importantly, the inclusion of heparinase increased the number of interpretable results across assays, improving reliability in heparinized samples.
What You Should Know:
The TEG® 6s Heparin Neutralization cartridge provides accurate and consistent coagulation data even in the presence of heparin, offering clinicians a reliable point-of-care option during cardiac and vascular procedures. While its analytical validity is now established, future prospective studies with clinical outcome measures are warranted to confirm its impact on transfusion management, bleeding control, and patient safety.
References:
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Da Luz LT et al. J Trauma Acute Care Surg. 2014;77(3 Suppl 1):S83–S91.
Sivapalan P et al. Anesth Analg. 2022;135(4):759–770.
Thank you to Anesthesiology for publishing this validation of the TEG® 6s Heparin Neutralization cartridge in cardiovascular practice.