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

Objective: Evaluate the relationship between initial haemostatic parameters and the frequency and severity of bleeding in neonates with hypoxic–ischaemic encephalopathy (HIE). Design: Retrospective observational cohort study. Setting: 2 academically affiliated level III neonatal intensive care units in Atlanta, Georgia. Participants: 98 neonates with moderate-to-severe HIE who underwent haemostatic testing within 12 hours of birth and were born from 1 January 2008 to 31 December 2013. Primary and secondary outcome measures: Initial haemostatic dysfunction was defined as one or more of the following: prothrombin time (PT) ≥18 s, platelet count <100×103/μL or fibrinogen <150 mg/dL. Bleeding assessed using the Neonatal Bleeding Assessment Tool and graded according to the WHO bleeding scale. The robust Poisson regression was used to evaluate the independent association between components of initial haemostatic dysfunction and bleeding. Results: Among the 98 neonates evaluated, the prevalence of initial haemostatic dysfunction was 69% (95% CI 59% to 78%). 27 neonates (28%; 95% CI 19% to 38%) had abnormal bleeding events and 56 (57%) received at least 1 blood product transfusion. 3 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 to 5.36) and platelet count <100×103/μL (adjusted relative risk 2.59, 95% CI 1.30 to 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, haemostatic 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.

研究目标：评估缺氧缺血性脑病（hypoxic–ischaemic encephalopathy, HIE）新生儿的初始止血参数与出血发生频率及严重程度之间的关联。
研究设计：回顾性观察队列研究。
研究场景：位于美国佐治亚州亚特兰大的2所附属学术机构的三级新生儿重症监护病房。
研究对象：2008年1月1日至2013年12月31日期间出生，且在出生后12小时内接受止血功能检测的98名中重度缺氧缺血性脑病新生儿。
主要及次要结局指标：初始止血功能异常定义为满足以下至少一项指标：凝血酶原时间（prothrombin time, PT）≥18秒、血小板计数<100×10³/μL或纤维蛋白原<150mg/dL。采用新生儿出血评估工具评估出血情况，并依据世界卫生组织（World Health Organization, WHO）出血分级标准进行分级。采用稳健泊松回归分析评估初始止血功能异常各组分与出血事件之间的独立关联。
研究结果：在纳入评估的98名新生儿中，初始止血功能异常的患病率为69%（95%置信区间：59%~78%）。27名新生儿（28%；95%置信区间：19%~38%）发生异常出血事件，56名（57%）接受了至少1次血液制品输注。3名新生儿因出血并发症死亡。最常输注的血液制品为新鲜冰冻血浆（占比71%），其次为悬浮红细胞（24%）及血小板（21%）。多变量分析结果显示，纤维蛋白原<150mg/dL（校正相对风险：2.41，95%置信区间：1.09~5.36）与血小板计数<100×10³/μL（校正相对风险：2.59，95%置信区间：1.30~5.16）与出血风险升高显著相关，而初始凝血酶原时间异常则无此关联。纤维蛋白原<150mg/dL的新生儿出血程度最为严重。
研究结论：在中重度缺氧缺血性脑病新生儿中，止血功能异常较为普遍，且与出血风险升高及高输血负担显著相关。未来仍需开展进一步研究，以明确该人群中适宜的输血策略，从而预防出血事件的发生。