Transfusing neonates based on platelet count vs. platelet mass: a randomized feasibility-pilot study.
The objective of this study was to obtain pilot data on which to judge the feasibility and sample size needed for a future comparative-effectiveness trial of platelet transfusions in the NICU. We conducted a limited-scope pilot trial in which neonates were randomized to receive platelet transfusions based on platelet mass vs. platelet count, using preset "transfusion-trigger" values. Analysis included parental consent rate, number of platelet transfusions given, bleeding episodes recorded, and mortality rate. Statistical analysis included ANOVA and Chi-square. A convenience sample of 30 were randomized; 15 per group. No differences were found between groups in gestational age, birth weight, race, gender or clinical diagnoses. The study consent rate was 52% (30/58). No differences were found in number of platelet transfusions received, bleeding episodes, or mortality. Lack of a trend in transfusion-reduction resulted in inability to estimate the number needed in a future comparative-effectiveness trial. Using platelet mass, rather than platelet count, for a NICU platelet transfusion trigger is feasible. However, any future comparative-effectiveness trial, testing the hypothesis that a platelet mass-based trigger reduces the transfusion rate will likely require a very large sample size.
Department of Neonatology, Einstein Medical Center Montgomery , East Norriton, PA , USA .
Jody L
JL
Zisk
Amy
A
Mackley
Gerrard
G
Clearly
Eddie
E
Chang
Robert D
RD
Christensen
David A
DA
Paul
D001792:Blood Platelets / Q000166:cytology*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D010865:Pilot Projects; D010976:Platelet Count; D017713:Platelet Transfusion / Q000379:methods*; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000097:blood* / Q000628:therapy*
Neonatal intensive care unit; neonatal platelet transfusions; platelet mass; platelet transfusion; thrombocytopenia