The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
Karolinska Institutet
Summary
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.
Description
Thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. However, there is a poor correlation between degree of thrombocytopenia and bleeding risk. A better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. The investigators recently found that the Platelet Function Analyzer (PFA) Closure Time-Collagen/ADP (CT-ADP) was a bet…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a gestational age \<32 weeks and a birth weight ≥500 grams; * Have a platelet count \<100 x 109/L; and * Have a parent/guardian willing to provide written informed consent. Exclusion Criteria: * Are not expected to survive for \>24 hours by the Attending Neonatologist; * Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
Locations (8)
- Boston Children's HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Intermountain Medical CenterMurray, Utah
- Utah Valley HospitalProvo, Utah
- Amsterdam University Medical CentreAmsterdam
- Leiden University Medical CenterLeiden