Key result
A therapeutic ACT cut-off value of >400 seconds on the Hemochron Signature Elite device reasonably approximates the standard >480 seconds on the Hemochron Response device.
Why the study?
To evaluate the Hemochron Elite activated clotting time device, which requires approximately 1/10th the blood sampling volume, relative to the Hemochron Response device during pediatric cardiopulmonary bypass.
Does the Hemochron Signature Elite ACT device correlate with the Hemochron Response device for monitoring heparin therapy in pediatric patients undergoing cardiopulmonary bypass?
Observational (n=260)
No
Does the Hemochron Signature Elite ACT device correlate with the Hemochron Response device for monitoring heparin therapy in pediatric patients undergoing cardiopulmonary bypass?
Answers are grounded in this paper and cite their sources.
Transitioning to the Hemochron Elite device, which requires significantly less blood volume, is feasible in pediatric congenital cardiac surgery when using an adjusted therapeutic ACT cut-off of >400 seconds.
Heparin is the primary anticoagulant used during cardiac surgery to prevent thrombosis due to cardiopulmonary bypass (CPB)–related activation of the hemostatic system. The efficacy of heparin in the operating room is generally determined by activated clotting time (ACT) point-of-care tests performed throughout the procedure. In an effort to transition to the Hemochron Elite which requires approximately 1/10th the sampling volume of blood, we conducted a prospective study in 260 pediatric patients undergoing CPB. ACT tests were performed during CPB with a total of 260 pre-bypass and 1,117 on-bypass ACT values recorded. All samples were run simultaneously on both ACT devices. Several therapeutic cut-off possibilities ranging from >380 to >480 seconds were evaluated to ascertain the ACT level on the Elite device which best correlated with results from the Response device. Linear regression was used to determine correlation. The correlation between the two methods was moderate with a Pearsonrof .6 and .4 for pre-bypass bolus ACT values and on-bypass ACT values, respectively. As the therapeutic ACT cut-off values were lowered from 480 to 380 seconds on the Elite device relative to the Response device (>480 seconds) for the on-bypass heparin samples, more patients would be under-dosed (incidence rising from 1 to 2%) and fewer patients would be overdosed (incidence decreasing from 32 to 5%) and the percent correlation between devices increased from 67 to 93%. A similar trend was observed with the pre-bypass heparin bolus samples. There was no significant effect of temperature on the ACT values comparing both devices. A therapeutic ACT value of >400 seconds for CPB with the Hemochron Elite device reasonably approximates a therapeutic ACT value of >480 seconds on the Hemochron Response device in our congenital cardiac surgery practice. Transitioning to the Elite device significantly reduces the overall sampling volume required for ACT monitoring during cardiac surgery.
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Matte et al. (2019) conducted an observational in Congenital heart disease requiring cardiopulmonary bypass (n=260). Hemochron Signature Elite ACT device vs. Hemochron Response ACT device was evaluated on Correlation between Hemochron Elite and Hemochron Response ACT values to determine a comparable therapeutic cut-off (Pearson r = 0.6 (pre-bypass) and 0.4 (on-bypass)). A therapeutic ACT cut-off value of >400 seconds on the Hemochron Signature Elite device reasonably approximates the standard >480 seconds on the Hemochron Response device.
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