To date, clinical experience with prothrombin complex concentrate (PCC) in the neonatal population has been limited.
The objective of this study was to describe our experience regarding the effectiveness and safety of PCC administration in newborns with severe bleeding or coagulopathy resistant to conventional therapy.
We retrospectively analyzed data from 37 neonates with intractable bleeding or severe coagulation disturbances. All patients received intravenous bolus administration of 20 or 30 u/kg of PCC per dose, as a rescue procedure.
Hemostasis was achieved in the majority of neonates and we observed statistically significant improvement in prothrombin time, international normalized ratio, and activated partial thromboplastin time (P<0.001, P=0.044, P<0.001, respectively). Thirteen neonates survived, whereas 24 did not survive. In those who survived, PCC had been administered earlier (<24 h) in the disease process compared with those who died (P=0.043). Neither acute adverse events nor thromboembolic complications were observed in all neonates.
In our study, PCC seemed to be a safe and effective intervention for hemostasis and early intervention was more effective as a rescue therapy, without any adverse event. Further prospective controlled trials are required to determine optimal dose and timing of PCC administration in neonates.
*2nd Neonatal Department and Neonatal Intensive Care Unit (NICU), Aristotle University of Thessaloniki
‡Pharmaceutical Department, “Papageorgiou” Hospital, Thessaloniki, Greece
The authors declare no conflict of interest.
Reprints: Georgios Mitsiakos, MD, PhD, 2nd Neonatal Department and Neonatal Intensive Care Unit, Aristotle University of Thessaloniki, “Papageorgiou” Hospital, Ring Road, Nea Efkarpia, PC 56403, Greece (e-mail: email@example.com).
Received March 4, 2018
Accepted November 30, 2018