Measurement of Activated Coagulation Time in Children: Evaluation of the Blood-Saving Kaolin i-STAT Activated Coagulation Time Technique in Pediatric Cardiac Anesthesia

ObjectiveTo compare the activated coagulation times (ACTs) measured with the blood-saving kaolin i-STAT 1 ACT technique (Abbott Point of Care Inc, Princeton, NJ) with ACTs obtained from the widely used ACTR II device (Medtronic, Inc, Minneapolis, MN) in children undergoing cardiac surgery.DesignA prospective, observational single-center study.ParticipantsForty-four pediatric cardiac surgery patients.InterventionSurgery was performed with cardiopulmonary bypass (CPB) necessitating heparinization.Methods and Main ResultsACTs measured on the i-STAT 1 device (2 × 95 μL) were compared with those obtained from the Medtronic ACTR II device (2 × 0.5 mL). Blood samples were drawn before, during, and after heparinization for CPB and paired for statistical analysis. The 2 techniques were compared using simple and multiregression analyses and the Bland-Altman method. In total, 179 intrarater and 142 interrater data pairs were analyzed. The intrarater reliability of the 2 devices was good, with a mean bias and limits of agreement of +2.0 and −55.5/+59.5 seconds for the Medtronic ACTR II and +0.5 and −59.9/+60.9 seconds for the i-STAT 1. An interrater reliability analysis of the mean of simultaneously measured ACT of the Medtronic ACTR II and both i-STAT 1 devices yielded a mean bias of −5.3 seconds and limits of agreement of −210.1/+199.5 seconds. A comparison of the higher of the paired ACT values from both devices showed similar results. After the removal of heparin, the i-STAT 1's ACT values became significantly lower than those measured on the Medtronic ACTR II (p < 0.001). Simple and multiregression analyses revealed that base excess independently influenced the mean bias of the ACT values from the Medtronic ACTR II (p = 0.037) and i-STAT 1 devices (p = 0.036).ConclusionThe kaolin i-STAT 1 ACT technique agreed well with the Medtronic ACTR II technique during the nonheparinized phase that preceded CPB. The overall agreement between the ACT obtained from the 2 devices was poor. The routine use of i-STAT 1 measured ACT values cannot be recommended as a reliable alternative to the Medtronic ACTR II.