Abstract

Fresh frozen plasma (FFP) is largely misused in the neonatal setting. The aim of the study is to evaluate the impact of a Thromboelastography (TEG)-based Quality Improvement (QI) project on perioperative FFP use and neonatal outcomes. Retrospective pre-post implementation study in a level-III NICU including all neonates undergoing major non-cardiac surgery before (01–12/2017) and after (01–12/2019) the intervention. In 2018, the intervention included the following: (1) Training on TEG, (2) Implementation of TEG, and (3) Algorithm for TEG-directed FFP administration in surgical neonates. We compared pre- vs post-intervention patient characteristics, hemostasis, and clinical management. Linear and logistic regression models were used to evaluate the impact of the project on main outcomes. We analyzed 139 neonates (pre-intervention: 72/post-intervention: 67) with a mean (± SD) gestational age (GA) 34.9 (± 5) weeks and birthweight 2265 (± 980) grams which were exposed to 184 surgical procedures (pre-intervention: 91/post-intervention: 93). Baseline characteristics were similar between periods. In 2019, prothrombin time (PT) was longer (14.3 vs 13.2 s; p < 0.05) and fibrinogen was lower (229 vs 265 mg/dl; p < 0.05), if compared to 2017. In 2019, the intraoperative exposure to FFP decreased (31% vs 60%, p < 0.001), while the pre-operative FFP use did not change. The reduction of intraoperative FFP did not impact on mortality and morbidity. Intraoperative FFP use was lower in the post-intervention even after controlling for GA, American Society of Anesthesiologists score, PT, and fibrinogen (Odds ratio: 0.167; 95% CI: 0.070, 0.371). Conclusion: The TEG-based QI project for the management of FFP during neonatal surgery reduced intraoperative FFP exposure.What is Known:• PT and aPTT are poor predictors of bleeding risk in acquired neonatal coagulopathy, leading to likely unnecessary fresh frozen plasma (FFP) transfusion in the Neonatal Intensive Care Setting. • As neonatal hemostasis is a delicate balance between the concomitant reduction of pro- and anti-coagulants drivers, thromboelastography (TEG) is a promising alternative for coagulation monitoring.What is New:• The implementation of TEG, training, and shared protocols contributed to reduced intraoperative FFP use, which was not associated with increased mortality or bleeding events.• These findings inform future research showing that there is clinical equipoise to allow for larger studies to confirm the use of TEG in NICUs and to identify TEG cut-offs for transfusion practice.

Highlights

  • Ill neonates are frequently exposed to blood products

  • As neonatal hemostasis is a delicate balance between the concomitant reduction of pro- and anti-coagulants drivers, thromboelastography (TEG) is a promising alternative for coagulation monitoring

  • The implementation of TEG, training, and shared protocols contributed to reduced intraoperative fresh frozen plasma (FFP) use, which was not associated with increased mortality or bleeding events

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Summary

Introduction

Fresh frozen plasma (FFP) transfusion is the most frequent intervention, being around 10% of all admissions to the Neonatal Intensive Care Units (NICUs) [1, 2]. This rate increases among extremely premature infants at risk of hemorrhagic events [1]. Current neonatal transfusion guidelines consider the use of FFP for (1) active bleeding with associated coagulopathy defined by abnormal coagulation tests [Prothrombin Time (PT); Activated Partial Thromboplastin Time (aPPT) and fibrinogen] and (2) increased risk of bleeding associated with coagulopathy [2]. The main reasons for non-compliance to guidelines were represented by the use of FFP as volume expander, bleeding without coagulopathy, and septic newborns without bleeding or coagulopathy [3]

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