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Effectiveness and Safety of 4-factor Prothrombin Complex Concentrate (4PCC) in Neonates With Intractable Bleeding or Severe Coagulation Disturbances

A Retrospective Study of 37 Cases

Mitsiakos, Georgios, MD, PhD*; Karametou, Margarita, MD*; Gkampeta, Anastasia, MD, PhD*; Karali, Crysa, MD*; Papathanasiou, Aimilia Eirini, MD, MSc*; Papacharalambous, Efthimia, MD*; Babacheva, Evgenyia, MD*; Papadakis, Emmanouil, MD; Yupsani, Anastasia, MSc; Chatziioannidis, Ilias, MD, MSc, PhD*; Soubasi, Vassiliki, MD, PhD*

Journal of Pediatric Hematology/Oncology: April 2019 - Volume 41 - Issue 3 - p e135–e140
doi: 10.1097/MPH.0000000000001397
Online Articles: Original Articles
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Background: To date, clinical experience with prothrombin complex concentrate (PCC) in the neonatal population has been limited.

Aim: 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.

Methodology: 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.

Results: 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.

Conclusions: 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

Hematology Department

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: mitsiakos@auth.gr).

Received March 4, 2018

Accepted November 30, 2018

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