Key result
ROTEM reference intervals confirm Danish data but fall below manufacturer guidelines for ARATEM and ADPTEM.
Why the study?
The study aimed to verify newly established Danish reference intervals and manufacturer-published values for ROTEM platelet impedance aggregometry in a local population.
Are the reference intervals for platelet aggregation assessed by ROTEM in Southern European healthy volunteers comparable to Danish and manufacturer populations?
Observational (n=40)
Are the reference intervals for platelet aggregation assessed by ROTEM in Southern European healthy volunteers comparable to Danish and manufacturer populations?
ROTEM platelet aggregometer reference intervals in a Southern European population match Danish reference intervals but differ from manufacturer values, supporting the use of population-verified reference ranges.
Answers are grounded in this paper and cite their sources.
Supports local verification of ROTEM platelet reference intervals; confirms Danish ranges while challenging manufacturer guidelines.
BACKGROUND: This study aimed to verify the reference intervals (RIs) recently established in the Danish population for platelet aggregation induced by a specific agonist of the rotational thromboelastometry (ROTEM) platelet impedance aggregometer. Our local results were also compared with those published by the manufacturer. METHODS: This prospective study included healthy blood donors. Subjects with a history of coagulopathy, those on antiplatelet/anticoagulant therapy, or those taking nonsteroidal anti-inflammatory drugs were excluded. Blood samples were collected for ROTEM® platelet arachidonic acid thromboelastometry (ARATEM), adenosine-di-phosphate thromboelastometry (ADPTEM), and thrombin receptor-activating peptide-6 thromboelastometry (TRAPTEM). The parameters determined were the area under the curve (AUC, ohm·min), maximum amplitude at 6 min (A6, ohm), and maximum slope (MS, ohm/min). Values are expressed as 2.5th-97.5th percentiles. Comparisons are expressed as local vs Danish and manufacturer population RIs. Number (n) and percentage (%) of local tests below (<2.5th percentile) of the Danish and manufacturer population are shown. RESULTS: Forty donors (19 male; mean, 58 [range: 56 to 60] years) were included. There were no differences between our results and those published for the Danish population. In contrast, all ARATEM and ADPTEM values were lower in the local vs manufacturer group. CONCLUSIONS: Our results confirm those published for the Danish population, with respect to the ROTEM platelet aggregometer. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT02652897.
No takes yet. Share an insight, caveat, or question.
Leal‐Noval et al. (2023) conducted an observational in Healthy volunteers (n=40). ROTEM platelet impedance aggregometer vs. Danish population and manufacturer reference intervals was evaluated on Platelet aggregation parameters (AUC, A6, MS) for ARATEM, ADPTEM, and TRAPTEM. ROTEM platelet aggregometer reference intervals in 40 healthy volunteers confirmed the Danish population reference intervals, but ARATEM and ADPTEM values were lower than manufacturer guidelines.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: