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Transfusion of Prematures Trial
Not Recruiting
Trial ID: NCT01702805
Purpose
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for
transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the
primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months
of age, using standardized assessments by Bayley.
Official Title
Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
Eligibility
Inclusion Criteria:
- Birth weight less than or equal to 1000 grams.
- Gestational age at least 22 weeks but less than 29 weeks
- Admitted to the NICU within 48 hours of life
Exclusion Criteria:
- Considered nonviable by the attending neonatologist
- Cyanotic congenital heart disease
- Parents opposed to the transfusion of blood
- Parents with hemoglobinopathy or congenital anemia
- In-utero fetal transfusion
- Twin-to-twin transfusion syndrome
- Isoimmune hemolytic disease
- Lack of parental consent
- Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for
perioperative transfusion.
- Prior blood transfusion on clinical grounds beyond the first 6 hours of life
- Infant has received erythropoietin prior to randomization, or is intended to receive
erythropoietin through the neonatal course
- Congenital condition, other than premature birth, that adversely affects life
expectancy or neurodevelopment.
- High probability that the family is socially disorganized to the point of being unable
to attend follow-up at 22-26 months.
Intervention(s):
procedure: Liberal Cell Transfusion
procedure: Restricted red cell transfusion
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P. Van Meurs, MD
650-723-5711