Status:
COMPLETED
PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Sanquin Research & Blood Bank Divisions
Amsterdam University Medical Center
Conditions:
Neonatal Thrombocytopenia
Intraventricular Hemorrhage
Eligibility:
All Genders
22-34 years
Brief Summary
Preterm neonates often receive platelet transfusions when their platelet count is low to prevent bleeding. However, it is currently unclear which infants benefit from such transfusions. A recent rando...
Detailed Description
Main objective: To develop a sequential interventional prediction model to support transfusion decisions by predicting the risk of major bleeding or death with and without giving a platelet transfusio...
Eligibility Criteria
Inclusion
- Gestational age at birth \<34 weeks;
- At least one platelet count \<50x109/L;
- Admission to a participating tertiary care NICU, including postnatal transfers, between January 1st, 2017 and January 1st, 2022.
Exclusion
- A severe congenital malformation;
- Only spurious platelet counts \<50x109/L (e.g. clots in the sample, or a very rapid recovery to a normal platelet count without platelet transfusion);
- Only platelet counts \<50x109/L in the context of exchange transfusion;
- Major intracranial bleeding prior to the onset of severe thrombocytopenia. Neonates with major bleeding after the end of follow-up will not be excluded, but will be recorded as having had no major bleeding during the study.
Key Trial Info
Start Date :
September 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
1042 Patients enrolled
Trial Details
Trial ID
NCT06043050
Start Date
September 26 2022
End Date
April 30 2024
Last Update
September 9 2025
Active Locations (12)
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1
Charité - Universitätsmedizin Berlin
Berlin, Metropolregion Berlin-Brandenburg, Germany, 10117
2
Radboud University Medical Center, Amalia Children's hospital
Nijmegen, Gelderland, Netherlands, 6525 GA
3
Maastricht University Medical Center, MosaKids
Maastricht, Limburg, Netherlands, 6229 HX
4
Máxima Medical Center
Veldhoven, North Brabant, Netherlands, 5504 DB