Multicenter study on the interference of spontaneous hemolysis at blood sampling on five main hemostasis tests in Research and Practice in Thrombosis and Haemostasis
2017
AO Cuneo
AOU Città della Salute di Torino
ASL Novara
Tipo pubblicazione
Conference Abstract
Autori/Collaboratori (19)Vedi tutti...
Novelli C
Morelli B
Vidali M
et alii...
Abstract
Background: Hemolysis is the first cause of rejection in hemostasis samples. Many studies demonstrate the effect of hemolysis on coagulation tests using artificially hemolyzed samples. New coagulometers able to identify optical interferences in order to replace visual inspection have been released. Aims: To evaluate the impact of spontaneous in vitro hemolysis on the main five hemostasis tests, hemolyzed samples (Es) were compared with another non-hemolyzed (NEs) specimen obtained from the same patient within 4h. Methods: A multicenter study involved 15 hospitals for the collection of paired samples (Es + NEs). 200 pairs of frozen plasma were analyzed with ACL TOP 750 CTS (IL) for 5 tests: PT, aPTT, D-Dimer (DD), Fibrinogen (Fib) and Antithrombin (AT). Critical difference (CD) between Es and NEs for each analyte was calculated as 2.77x(CVa2+CVi2)1/2 (CVa=analytical coefficient of variation, CVi =within-subject biological variation). Bias between Es and NEs was evaluated by Bland-Altman analysis. Results: Median values for all tests and median free hemoglobin (IQR, min-max) for Es and NEs are shown in Tab1. Mean bias (95% of the differences Es-NEs) was -0.1s(-7.9 to 7.6) for PT, -1.1s(-12.3 to 10.0) for aPTT, 1366ng/mL(-12650 to 15383) for DD, -4mg/ dL(-130 to 122) for Fib and 1.2%(-17 to 19) for AT. Differences beyond critical limit based on CVa and CVi were 9.5% for PT, 37% for aPTT, 13% for DD, 5.5% for Fib and 5% for AT. Correlations (r) between free hemoglobin concentration and E-NE differences were 0.17(PT), 0.17(aPTT), -0.04(DD), 0.22(Fib) and -0.08(AT). All DD differences >10000ng/mL(n=10) had aPTT ratio < 0.86. Mean bias for DD, without these samples, falls to 61.7ng/mL(-1977 to 2100). Conclusions: Our data suggest that in vitro hemolysis does not affect PT, Fib and AT. A moderate bias and a significant difference was instead observed for DD, and to some extent to aPTT, but at least some largest discrepancies are likely due to interferences different
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DOI : 10.1002/rth2.12012
Keywords
male; middle aged; major clinical study; Italy; ICD-9; incidence; human; hospitalization; hospital mortality; hospital admission; gender; diagnosis; female; conference abstract; controlled study; Charlson Comorbidity Index; case fatality rate; cerebral sinus thrombosis; brain hemorrhage; adult; regression analysis;