Randomized, Controlled Trial of Individualized Heparin and Protamine Management in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Abstract

This study supports the use of the HMS device, with a modified protocol for infants younger than 1 year of age, for anticoagulation management during CPB. Clinical guidelines for the use of the HMS device should be modified for infants younger than 1 year of age.

Factors affecting consent in pediatric critical care research

“…Many pediatric critical care studies have, in fact, not reported the consent rate in their manuscripts [21,22] making it difficult for researchers to obtain this information. The consent rates provided in this study will allow researchers to estimate sample sizes, recruitment rates, budgets, and timelines for future pediatric critical care studies.…”

Risk, Clinical Features, and Outcomes of Thrombosis Associated With Pediatric Cardiac Surgery

“…14,18 -21 Neonates already have low levels of antithrombin, protein S and protein C activity (typically between 20% and 60% of adult levels), contact factors (XI, XII, PK, HMWK), and vitamin K-dependent factors (II, VII, IX, X) (all Ͻ70% of adult values). 3 Many of these differences are associated with lower capacity to inhibit thrombin generation, increased heparin clearance, 22 and decreased sensitivity to anticoagulants, 23 particularly to standard heparin, the most commonly used agent during and after surgery. The initiation of cardiopulmonary bypass can result in a further 50% decrease in circulating coagulation factors and antithrombin levels, in addition to a 70% drop in platelet counts.…”

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

“…Guzzetta and colleagues 381 studied infants <6 months of age and failed to identify a decrease in blood loss or transfusion in these younger patients. More recently, Gruenwald and colleagues 382 reported on the outcomes of 90 patients <1 year of age randomized to either weight-based ACT-guided dosing or the Hepcon HMS device. The authors found that Hepcon HMS underestimated the anti-FXa level and therefore resulted in a higher heparin dose in the Hepcon HMS group.…”

“…It is noteworthy, however, that the authors could not demonstrate a difference in chest tube output. 382 The available POC tests to guide anticoagulation on CPB; the ACT and heparin concentration testing with HPT and the strategies of applying these tests; empirical weight-based ACT-guided dosing, HDRC, and combined HDRC-HPT have been shown to have variable correlation with heparin activity as determined by anti-FXa levels. An understanding the limitations of these tests and strategies especially when applied to the smallest and youngest patients is essential to the safe conduct of CPB.…”

“…The investigators found that patients randomized to the Hepcon HMS received less protamine and had less evidence of hemostatic activation, but a reduction in blood product transfusion was not demonstrated. 381 More recently, using a modified protocol in which the protamine dose given was 1.5 times that indicated by the Hepcon HMS, Gruenwald and colleagues 382 found that infants managed with the Hepcon HMS had decreased blood transfusions, shorter intensive care unit length of stay, and shorter duration of mechanical ventilation, but the authors could not demonstrate a difference in chest tube output. Regardless of the specific strategy to determine the quantity of protamine necessary for reversal of heparin, an ACT or heparin level as determined by HPT is measured 5 to 10 minutes after protamine administration to confirm satisfactory reversal.…”