Point-of-Care Measurement of Kaolin Activated Clotting Time during Cardiopulmonary Bypass:A Single Sample Comparison between ACT Plus and i-STAT

Heparin anticoagulation monitoring by point-of-care activated clotting time (ACT) is essential for cardiopulmonary bypass (CPB) initiation, maintenance, and anticoagulant reversal. Concerns exist regarding the comparability of kaolin activated ACT devices. The current study, therefore, evaluated the agreement of ACT assays using parallel measurements performed on two commonly used devices. Measurements were conducted in a split-sample fashion on both the ACT Plus (Medtronic, Minneapolis, MN) and i-STAT (Abbott Point of Care, Princeton, NJ) analyzers. Blood samples from 100 adult patients undergoing elective cardiac surgery with CPB were assayed at specified time points: before heparinization, following systemic heparinization, after CPB initiation, every 30 minutes during CPB, and following protamine administration. A cutoff value of 400 seconds (s) was used as part of the local protocol. Measurements were compared using t tests or Wilcoxon signed-rank tests, linear regression, and Bland-Altman analyses. Parallel ACT measurements demonstrated a good linear correlation (r = .831, p < .001). The overall median difference between both measurements was significantly different from zero, amounting to 87 (14-189) (p < .001), with limits of agreement of -124 and 333s. The i-STAT-derived ACT values were systematically lower than the ACT Plus values, which was more pronounced during CPB. Fourteen patients received additional heparin during CPB at a median ACT Plus value of 414s, with a concomitant median i-STAT value of 316s. Assuming 308s as the theoretical i-STAT cutoff value based on the linear regression equation and an ACT Plus threshold of 400s, 29 patients would have received additional heparin. Based on these results, kaolin point-of-care ACT devices cannot be used interchangeably. Device-specific predefined target values are warranted to avert heparin overdosing during CPB.