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

Bleeding Neonatal Thrombocytopenia

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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