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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., (© 2022. The Author(s).)

Objective: We determined thromboelastographic (TEG) profiles of healthy very low birthweight infants (VLBWIs) of the day of birth and at set intervals during their first month., Design: Prospective observational study with blinded clinical and laboratory follow-up., Setting: Level III neonatal intensive care unit (June 2015 to June 2018)., Patients: Consecutive qualifying VLBWIs were enrolled at birth and followed up for 30 days., Interventions and Main Outcomes Measures: Laboratory (citrated-native TEG, prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, blood count) and clinical variables were retrieved at birth, 3rd-5th, 10th and 30th day of life. Blood samples temporally related to events with a potential hemostatic impact (sepsis, bleeding, platelets/plasma transfusions, ibuprofen/indomethacin administration) were excluded from analysis., Results: We enrolled 201 VLBWIs and 72 full-term neonates. Sixty-seven of the healthy VLBWIs completed the 30-day follow-up. 541 TEG traces were analysed.On day 1, the median (minimum-maximum) TEG values were as follows: reaction time (R), 8.2 min (1-21.8); kinetics (K), 2.8 min (0.8-16); α angle, 51° (14.2-80.6); maximum amplitude (MA), 54.9 mm (23.9-76.8). PT and APTT were 15.9 s (11.7-51.2) and 59 s (37.8-97.5), respectively. The above parameters suggest minor hypocoagulability compared with term infants. On day 30, the median (minimum-maximum) R was 5 (1-16.9), K 1 (0.8-4.1), α 74.7 (41.1-86.7) and MA 70.2 (35.8-79.7). PT and APTT were 12.1 (10.4-16.6) and 38.8 (29.6-51.4), respectively. Those parameters are consistent with a relatively hypercoagulable phenotype, compared with term infants., Conclusions: Healthy VLBWIs have a prolonged PT and APTT, but their TEG profiles suggest a relatively balanced hemostatic system, with slight hypocoagulability initially (compared with term neonates), gradually evolving to a somewhat more procoagulant phenotype over the first month., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)