Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months

With the advent of measures to try to decrease the incidence of transfusion-related acute
lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from
female donors who have been pregnant in order to reduce the transfusion of plasma that may
contain HLA antibodies. This has led to a decrease in the number of donors available for the
production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United
States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24
hours of collection is called FP24, and it is produced when whole blood cannot be processed
within the 8-hour time period for the generation of FFP. Studies of coagulation factors in
FFP and FP24 have shown that coagulation factor activities are adequate to maintain
hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults,
and occasional hospitals are using these products interchangeably in neonates. However,
studies concerning the use of FP24 in neonates have not been performed.

The investigators propose a single center prospective pilot study comparing the clinical
efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring
plasma for an International Normalization Ratio (INR) of 1.5 or more.

This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical
neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or
necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg)
is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated
by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin
time (PTT), and INR.