Abstract
Abstract 4400
Fresh frozen plasma (FFP) has been recommended for treating a variety of pediatric clinical scenarios, although these recommendations are based on limited data, with very few randomized controlled trials demonstrating a benefit of FFP. Several recent publications both in the pediatric and adult literature have questioned the efficacy of FFP in many previously recommended therapies. Therefore, the objectives of our study were to review the use of FFP in U.S. pediatric hospitals and to determine the prevalence, potential complications and pattern of use.
This retrospective multicenter cohort study used data from the Pediatric Health Information System (PHIS) database, an administrative database that contains inpatient data from 41 tertiary care pediatric hospitals. The cohort included children < 19 years who received FFP from 2002 to 2009. Statistical analysis included descriptive statistics and linear regression analysis to evaluate rate of FFP use and mortality over time.
During the duration of this study, 3,338,564 children were admitted to the participating hospitals. Of these, 101,456 (3%) received FFP. Children under 1 year of age accounted for the majority (53%) of all FFP infusions. The prevalence of FFP use over time is shown in figure 1. Use of FFP among all hospital admissions did not demonstrate a significant change during the course of this study (from 2.8% in 2002 to 2.8% in 2009). Although the proportion of NICU admissions receiving FFP did demonstrate a significant increase over time, from 2008 to 2009 there was a statistically significant decrease. There was no statistically significant change in PICU FFP use over time, however the use has decreased each year since 2006. The most common probable indication for FFP was cardiopulmonary bypass, which occurred in 34% of children receiving FFP. Ten percent of children receiving FFP had an associated venous thrombotic event, while 4.8% had an arterial event. The rate of arterial thrombosis did not change significantly during the course of this study, but the rate of venous thrombosis increased from 3.8% to 13.1%. This parallels the rise in venous thrombosis recently reported in all hospitalized children, although the likelihood of a venous thrombosis in children receiving FFP is at least ten-fold higher. The overall mortality rate of children receiving FFP was 16%, but demonstrated a statistically significant decrease from 17.9% in 2002 to 13.9% in 2009 (p=0.002).
This large epidemiologic study helps to describe FFP use in U.S. tertiary care pediatric hospitals. In our study, 3% of hospitalized children received FFP, despite the lack of published data regarding dose, efficacy and safety. Data from the most recent years suggests a possible trend towards decreasing use, although this needs to be further evaluated in upcoming years. Hospitalized children receiving FFP have at least a ten-fold increased likelihood of a venous thrombotic event compared to all hospital admissions. Since the timing of FFP use to thrombotic events could not be determined by this study, it is difficult to determine to what degree FFP may play a causative role in thrombosis and further investigation into this area is warranted. Given the lack of studies indicating the efficacy of FFP in children (outside of priming the pump for cardio-pulmonary bypass), our study demonstrates that the majority of FFP use in pediatric hospitals has yet to be supported by randomized clinical trials.
No relevant conflicts of interest to declare.
Author notes
Asterisk with author names denotes non-ASH members.