Assessing bleeding risk in preterm infants with low platelet counts
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
This study is trying to see if certain tests can better predict bleeding risks in preterm babies with low platelet counts to help doctors make safer treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 1 Day and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 8 sites (Boston, Massachusetts and 7 other locations) |
| Trial ID | NCT04598750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the Immature Platelet Fraction (IPF) and Platelet Function Analyzer-100/200 Closure Time-ADP as markers of bleeding risk in thrombocytopenic preterm neonates in the Neonatal Intensive Care Unit. The study seeks to improve the understanding of bleeding risks associated with thrombocytopenia, which is often poorly correlated with platelet counts. By comparing IPF with existing markers, the research intends to guide more accurate platelet transfusion decisions and minimize unnecessary risks for vulnerable infants. The study will also validate previous findings regarding the effectiveness of the PFA-100/200 CT-ADP in predicting bleeding in a larger cohort.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm neonates with a gestational age of less than 32 weeks and a platelet count below 100 x 10^9/L.
Not a fit: Patients who are not expected to survive for more than 24 hours or have familial thrombocytopenia or platelet dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of bleeding risk in neonates, potentially reducing unnecessary platelet transfusions and associated risks.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in using platelet function tests to assess bleeding risk in neonates.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Boston, Massachusetts and 7 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Not_yet_recruiting)
- Utah Valley Hospital — Provo, Utah, United States (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)
Study contacts
- Principal investigator: Emöke Deschmann, MD, PhD — Karolinska Institutet
- Study coordinator: Emöke Deschmann, MD, PhD
- Email: emoke.deschmann@regionstockholm.se
- Phone: +46 73 539 5575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.