Clinical Trials in the Netherlands / NCT04598750
Recruiting
Observational
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
NCT04598750 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Neonatal ThrombocytopeniaBleeding
Study 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
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).
Primary outcome measure(s)
- NeoBAT score — 24 hours
NeoBAT scores will include any bleeding since the last platelet count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores (NeoBAT) with platelet counts, IPF% and IPC, PFA-100/200 CT-ADP, and to quantify changes in response to platelet transfusions. The scale is 1 to 4 with 1 being Minor Hemorrhage and 4 being Severe Hemorrhage.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Not Yet Recruiting |
| Intermountain Medical Center | Murray | Utah | Not Yet Recruiting |
| Utah Valley Hospital | Provo | Utah | Not Yet Recruiting |
| Amsterdam University Medical Centre | Amsterdam | Netherlands | Not Yet Recruiting |
| Leiden University Medical Center | Leiden | Netherlands | Not Yet Recruiting |
| Karolinska University Hospital Huddinge campus | Huddinge | Sweden | Recruiting |
| Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital | Stockholm | Sweden | Recruiting |
Other trials for the same condition
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Amplatzer Amulet LAAO vs. NOAC
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04598750 on ClinicalTrials.gov ↗ ← All trials in the Netherlands