Key result
The Coaguchek Pro/DM bedside device substantially overestimated aPTT compared to laboratory assay in infants on heparin (positive bias 27 s), with disagreement increasing at higher values (P<0.001).
Why the study?
Does the Coaguchek Pro/DM bedside device accurately measure aPTT compared to a standard laboratory assay in infants on heparin therapy?
Observational (n=24)
Does the Coaguchek Pro/DM bedside device accurately measure aPTT compared to a standard laboratory assay in infants on heparin therapy?
Effect estimate: r = 0.48
p-value: p=<0.001
The Coaguchek Pro/DM bedside device overestimates aPTT in infants on heparin and should not be used for monitoring in the pediatric intensive care setting.
Supports caution with Coaguchek Pro/DM aPTT readings in heparin-treated infants; leaves open pediatric validation of point-of-care devices.
To determine the relationship between the activated partial thromboplastin time (aPTT) measured with a standard laboratory assay and the aPTT measured with a bedside device in infants on heparin therapy after cardiothoracic surgery. Twenty infants aged below 1 year who were on heparin therapy were included. Exclusion criteria were prematurity, dysmaturity and the use of anticoagulants other than heparin. Nineteen samples were obtained from four adults in intensive care who were on heparin. The aPTT values were analyzed with the Coaguchek Pro/DM bedside device (aPTTbed) and compared with the aPTT values obtained from the laboratory Electra 1800C coagulation analyzer (aPTTlab). Correlation analysis was performed by linear regression. The agreement was calculated using Bland-Altman analysis. The correlation coefficient of samples obtained from infants was lower (r = 0.48) compared with samples from adults (r = 0.85). A substantial positive bias (27 s) and scatter [95% confidence interval (CI) -11; +65 s) was found. The bias showed a genuine trend to increase at higher aPTT values (r = 0.90; P < 0.001). The bedside device overestimates the aPTT in infants treated with heparin. The disagreement between the bedside device and laboratory increases at higher aPTTs. Bedside devices should not be used to monitor heparin therapy in infants in intensive care.
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Klein et al. (2013) conducted an observational in Heparin therapy after cardiothoracic surgery (n=24). Coaguchek Pro/DM bedside device (aPTTbed) vs. Laboratory Electra 1800C coagulation analyzer (aPTTlab) was evaluated on Correlation and agreement between bedside and laboratory aPTT values (r = 0.48, p=<0.001). The Coaguchek Pro/DM bedside device substantially overestimated aPTT compared to laboratory assay in infants on heparin (positive bias 27 s), with disagreement increasing at higher values (P<0.001).
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