RecruitingNCT04598750
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
Sponsor
Karolinska Institutet
Enrollment
250 participants
Start Date
Jun 15, 2021
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 1 Day
Inclusion Criteria3
- 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 Criteria2
- 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).
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Locations(8)
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NCT04598750
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