title: Protein C concentrate as adjuvant treatment in neonates with sepsis-induced coagulopathy: a pilot study.
abstract: The objective of the study is to describe safety and effects of protein C concentrate (PCConc) administration in neonates with sepsis-induced coagulopathy. Eighteen neonates (12 preterm and 6 full term) aged between 1 and 28 days who have severe sepsis (n = 6) or septic shock (n = 12), with coagulopathy and acquired protein C (PC) deficiency received PCConc (i.v. bolus of 100 IU/kg, followed by 50 IU/kg every 6 h for 72 h). Platelet counts, prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer, C-reactive protein (CRP), antithrombin (AT), PC, CRP, and neonatal therapeutic intervention scoring system (NTISS) were assessed before and 24, 48, and 72 h after the study entry. According to Clinical Risk Index for Babies II score (CRIB II score), the expected mortality in preterms was 10%. After 24 h of treatment, PC activity levels increased from an average of 19% to 57%, and they were within normal limits before the last PCConc bolus. During the treatment period, a shortening of PT (P = 0.04) and activated partial thromboplastin time (P = 0.02), and an increase in antithrombin levels (P < 0.0001) were observed, along with a reduction in CRP (P = 0.005) and NTISS values (P = 0.003). No adverse events were observed. This pilot study shows that in neonatal severe sepsis, normalization of PC levels is safe and probably effective in modulating the inflammatory response and in controlling coagulopathy. However, for the potential beneficial effects of PCConc administration on morbidity and mortality, a placebo-controlled, double-blind study is required.
authors.affiliation: Neonatology and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. lidiadec@alice.it
authors.forename: Lidia
authors.initials: L
authors.lastname: Decembrino
authors.forename: Armando
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Franco
authors.initials: F
authors.lastname: Manzato
authors.forename: Agostina
authors.initials: A
authors.lastname: Solinas
authors.forename: Francesco
authors.initials: F
authors.lastname: Tumminelli
authors.forename: Annalisa
authors.initials: A
authors.lastname: De Silvestri
authors.forename: Sandro
authors.initials: S
authors.lastname: De Lazzari
authors.forename: Ezio
authors.initials: E
authors.lastname: Padovani
authors.forename: Mariella
authors.initials: M
authors.lastname: Magarotto
authors.forename: Lino
authors.initials: L
authors.lastname: Chiandetti
authors.forename: Sergio O
authors.initials: SO
authors.lastname: Saia
authors.forename: Mauro
authors.initials: M
authors.lastname: Stronati
mesh_terms: D000991:Antithrombins / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy* / Q000209:etiology* / Q000378:metabolism; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D011486:Protein C / Q000627:therapeutic use*; D018805:Sepsis / Q000150:complications* / Q000188:drug therapy* / Q000378:metabolism
chemical_list: D000991:Antithrombins; D011486:Protein C; D002097:C-Reactive Protein