Objective
Protamine is used to neutralize heparin after patient separation from cardiopulmonary
bypass (CPB). Different bedside tests are used to monitor the adequacy of heparin
neutralization. For this study, the interchangeability of the activated coagulation
time (ACT) and thromboelastometry (ROTEM; Tem Innovations GmbH, Basel, Switzerland)
clotting time (CT) ratios in children undergoing cardiac surgery was assessed.
Design
Single-center, retrospective, cohort study between September 2010 and January 2012.
Setting
University children’s hospital.
Participants
The study comprised children 0 to 16 years old undergoing elective cardiac surgery
with CPB. Exclusion criteria were preoperative coagulopathy, Jehovah’s witnesses,
and children in a moribund condition (American Society of Anesthesiologists score
5).
Interventions
None.
Measurements and Main Results
After heparin neutralization with protamine, the ratio between ACT, with and without
heparinase, and the CT measured with INTEM/HEPTEM (intrinsic test activated with ellagic
acid was performed without heparinase [INTEM] and with heparinase [HEPTEM]) using
tests of ROTEM were calculated. Agreement was evaluated using Cohen’s kappa statistics,
Passing-Bablok regression, and Bland-Altman analysis. Among the 173 patients included
for analysis, agreement between both tests showed a Cohen’s kappa statistic of 0.06
(95% CI: -0.02 to 0.14; p = 0.22). Bland-Altman analysis showed a bias of 0.01, with
a standard deviation of 0.13, and limits of agreement between -0.24 and 0.26. Passing-Bablok
regression showed a systematic difference of 0.40 (95% CI: 0.16-0.59) and a proportional
difference of 0.61 (95% CI: 0.42-0.86). The residual standard deviation was 0.11 (95%
CI: -0.22 to 0.22), and the test for linearity showed p = 0.10.
Conclusion
ACT, with or without heparinase, and the INTEM/HEPTEM CT ratios are not interchangeable
to evaluate heparin reversal after pediatric patient separation from CPB. Therefore,
the results of these tests should be corroborated with the absence/presence of bleeding
and integrated into center-specific treatment algorithms.
Key Words
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Article info
Publication history
Published online: July 22, 2016
Footnotes
This work was supported by the Department of Anesthesiology, Brugmann University Hospital, Brussels, Belgium. A.W. received a grant from the Belgian Fonds de la Recherche Scientifique Médicale (Research program No: 3.4580.11) and the Belgian Kid’s Fund for Pediatric Research. D.F. received a grant from the Belgian Kid’s Fund for Pediatric Research.
Identification
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© 2016 Elsevier Inc. All rights reserved.
