Reliability of a point-of-care device for international normalized ratio testing during the three surgical phases of orthotopic liver transplantation: a retrospective observational study.

Abstract

To investigate the reliability of a point-of-care device, the HEMOCHRON(®) Jr. Signature, for measuring the international normalized ratio (INR) during the three surgical phases of liver transplantation. A retrospective review was performed on patients undergoing liver transplantation during July to December 2013. Thirty-one patients who had simultaneous laboratory and point-of-care INR readings from each phase of liver transplant surgery (paleohepatic, anhepatic, and neohepatic) were eligible for inclusion. Bland-Altman analysis, Spearman's rank correlation, and four quadrant plots were used to compare INR results from the point-of-care device (pocINR) with those from the laboratory (labINR). Based on the Bland-Altman analysis, mean biases (95% prediction interval) were 0.10 (0.03 to 0.17), 0.19 (0.12 to 0.27), and 0.21 (0.01 to 0.43) for the paleohepatic, anhepatic, and neohepatic phases, respectively. The pocINR device showed a systematic underestimation of the labINR. The Spearman's rank correlation coefficients (95% confidence interval [CI]) were: Ρ=0.90 (95% CI 0.80 to 0.95); Ρ=0.92 (95% CI 0.71 to 0.93); and Ρ=0.71 (95% CI 0.46 to 0.85), respectively. Direction-of-change analysis between the paleohepatic to anhepatic and the anhepatic to neohepatic phases showed strong concordance of 84% and, also considering the small bias between the measurements, supports the use of the pocINR device in the clinical management of liver transplant surgery. Point-of-care INR was accurate prior to hepatic reperfusion, but reliability decreased in the neohepatic phase.