Data from: Observational study of hemostatic dysfunction and bleeding in neonates with hypoxic-ischemic encephalopathy

Objective: Evaluate the relationship between initial hemostatic parameters and the frequency and severity of bleeding in neonates with hypoxic-ischemic encephalopathy (HIE).
Design: Retrospective observational cohort study.
Setting: Two academically-affiliated level III neonatal intensive care units in Atlanta, Georgia.
Participants: Ninety-eight neonates with moderate-to-severe HIE who underwent hemostatic testing within 12 hours of birth and were born from 1/1/08 to 12/31/13.
Primary and secondary outcome measures: Initial hemostatic dysfunction was defined as one or more of the following: prothrombin time (PT) ≥ 18 sec, platelet count < 100x10³/μL or fibrinogen < 150 mg/dL. Bleeding assessed using the Neonatal Bleeding Assessment Tool and graded according to the World Health Organization bleeding scale. Robust Poisson regression was used to evaluate the independent association between initial hemostatic dysfunction and bleeding.
Results: Among the 98 neonates evaluated, the prevalence of initial hemostatic dysfunction was 69% (95% CI 59-78%). Twenty-seven neonates (28%; 95% CI 19-38%) had abnormal bleeding events and 56 (57%) received at least one blood product transfusion. Three neonates died from bleeding complications. The most common products transfused were fresh frozen plasma (71%), followed by packed red blood cells (24%) and platelets (21%). In multivariable analysis, fibrinogen < 150 mg/dL (adjusted relative risk 2.41, 95% CI 1.09-5.36) and platelet count < 100x10³/μL (adjusted relative risk 2.59, 95% CI 1.30-5.16), but not initial PT, were associated with an increased risk of bleeding. The most severe bleeding occurred in neonates with a fibrinogen <150 mg/dL.
Conclusions: Among neonates with moderate-to-severe HIE, hemostatic dysfunction is prevalent and associated with an increased risk of bleeding and high transfusion burden. Further studies are needed to determine the appropriate transfusion approaches in this population to prevent bleeding.