The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)
研究概览
简要总结
This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth weight <1500 grams and with different degrees of thrombocytopenia.
The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<32 weeks gestation or with a birth weight <1500 grams;
- •Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count <100x109/L;
- •Have a parent/guardian willing to comply with the protocol and provide written informed consent.
排除标准
- •Are not expected to survive by the Attending Neonatologist;
- •Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
- •Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.
结局指标
主要结局
Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)
时间窗: study period: 5 days
The NeoBAT is a simple, reliable and objective tool for the standardized assessment of bleeding in neonates, which was developed by an international team of experts based on the World Health Organization bleeding score for adults.
次要结局
- Number of thrombotic events(up to post-conceptional age 36 weeks)
研究者
Emoke Deschmann
M.D., M.M.Sc., Attending Neonatologist
Karolinska Institutet