Status: Funded - Open
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
Emöke Deschmann, M.D., M.M.Sc.
BACKGROUND: Thrombocytopenia affects 20-30% of infants admitted to the NICU, and up to 70% of infants born at <1000 grams. Thrombocytopenia is a risk factor for bleeding in neonates, which may lead to life-long consequences (intracranial bleeding), however, there is a poor correlation between degree of thrombocytopenia and bleeding risk.
GAP: Neonatal platelets are known to be hyporeactive, and their reactivity is influenced by several factors (including gestational and postnatal age, medications, etc.). Due to the hyporesponsiveness of neonatal platelets, it has been widely accepted that neonates should be transfused at higher platelet counts than older children or adults, however, it is unknown what truly constitutes a “dangerous” platelet count in this patient population, and which neonates might benefit from platelet transfusions. A bleeding risk marker may help physicians determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in thrombocytopenic neonates, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks.
HYPOTHESIS: 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.
METHODS: This is a prospective longitudinal study that evaluates PFA-100 CT-ADPs and incidence of bleeding (using the Neo-BAT) in preterm neonates <32 weeks gestational or with a birth weight <1500 grams and with different degrees of thrombocytopenia.
IMPACT: This study evaluates whether the CT-ADP is a better predictor of bleeding risk in thrombocytopenic neonates than the platelet count alone. If so, then perhaps PFA-100 CT-ADPs should be incorporated into the decision-making process regarding when to administer platelet transfusions to neonates in the NICU, thus reducing the exposure of neonates to unnecessary transfusions.
United States, United States, Sweden