Evaluation of the TAS Analyzer and the Low-Range Heparin Management Test in Patients Undergoing Extracorporeal Membrane Oxygenation

Background: The new Low-Range Heparin Management Test (LHMT), a method for point-of-care testing (POCT) of heparinization, has been designed to function at the low to moderate heparin concentrations typically found in patients undergoing extracorporeal membrane oxygenation (ECMO). In this study, the new method is compared with two POCT methods and a laboratory-based anti-Xa assay. Methods: We obtained 760 whole blood samples from 13 patients undergoing ECMO. All samples were tested immediately by the LHMT, the Activated Clotting Time (ACT) test, and its low-range counterpart (ACT-LR). Aliquots from the same blood draw were frozen for later anti-Xa analysis using the Diagnostica Stago method on the Roche Cobas Fara-II. Results: The precision was best for duplicate citrated LHMT samples (CV = 3.1%). LHMT clotting times (overall median, 162 s) were typically shorter than ACT or ACT-LR times (247 and 235 s, respectively). The relationship between the LHMT and the other POCT methods differed significantly from patient to patient (P <0.0001), and a meaningful single relationship between the methods could not be obtained. The overall correlation coefficient between clotting time values and actual heparin concentrations was ≤0.48 for each of the instruments tested, although time plots of each analyzer’s data suggested that they detected heparin dosage changes within single patients. Conclusions: The performance of the LHMT on the TAS Analyzer is equivalent to that of currently commercially available POCT methods. The lack of agreement between absolute clotting time values and heparin concentrations suggests the need for reexamination of current ECMO patient management strategy.