Role of prophylactic fresh frozen plasma in critically ill neonate to prevent bleeding in disseminated intravascular coagulation: a randomized controlled trial

Abstract

Background: Disseminated intravascular coagulation (DIC) has a high prevalence in critically ill neonates. In suspicion of DIC based on abnormal coagulation parameter is a common trigger to transfuse fresh frozen plasma (FFP), even in absence of bleeding. In past years, use of FFP has increased and has expanded to include prophylactic use in neonates especially in neonatal intensive care units (NICUs) as it contains several coagulation factors. Several studies suggest that, prophylactic use of FFP has no role to prevent bleeding in disseminated intravascular coagulation (DIC), but carries increase risk of transfusion related mortality and morbidity. Objective: To assess the effectiveness of prophylactic use of FFP in critically ill neonate to prevent bleeding in DIC. Methods: This randomized, open-label, blinded end-point study was conducted in Bangladesh Institute of Child Health and Dhaka Shishu (Children) Hospital from July, 2019 to June, 2021. Term, critically ill neonates who had underlying disease, suspected to develop DIC were conveniently selected. Later, they were randomly allocated using software in intervention group, who received 10 ml/kg of FFP along with standard management and control group, who received only standard management. Coagulation parameters were checked before and 24 hour after intervention in both groups. Outcome was occurrence of bleeding as a indicator of DIC. Results: The mean age was 8.55 ± 3.5 days in intervention and 8.92 ± 6.1 days in control group. Male patients were predominant. There was no significant difference in baseline characteristics between two groups. The difference of mean ± SD of coagulation parameters between two groups were nonsignificant before intervention. Even after FFP transfusion, DIC developed among 40.1% neonates in intervention and without FFP transfusion among 48.9% neonates in control group without any significant difference (P-value >0.05). Conclusion: Study result found no role of prophylactic use of FFP in critically ill neonate to prevent bleeding in DIC. Bangladesh Medical Res Counc Bull 2022; 48: 146-153