The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Recruiting now

Conditions studied: Neonatal Thrombocytopenia, Bleeding

In brief

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.

Key facts

Study ID

NCT04598750

Run by

Karolinska Institutet

People needed

250

Starts

2021-06-15

Expected to finish

2025-12-31

Last updated by the study team

2024-10-09

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Karolinska University Hospital Huddinge campus — Huddinge, Sweden (enrolling)
• Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital — Stockholm, Sweden (enrolling)
• Amsterdam University Medical Centre — Amsterdam, Netherlands
• Leiden University Medical Center — Leiden, Netherlands
• Utah Valley Hospital — Provo, Utah, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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