Abstract
The purpose of the study was to examine safety and efficacy of non-activated Protein C (PC) supplementation in our cohort of septic pediatric hematological patients. We conducted a retrospective study of 22 septic patients receiving human plasma-derived PC concentrate from 2008 to 2015 at our Pediatric Oncology Center (Bari, Italy). The Surviving sepsis campaign definitions for sepsis, severe sepsis and septic shock were used to define the patients’ septic status. For each patient, we calculated Lansky performance status scale (LPSS) and a risk score defined the Hematologic risk score (HRS) that we created in 2007. Patients were defined as High risk for severe sepsis/septic shock in case of HRS>3. HRS<3 identified low risk patients. Baseline serum PC levels, PC administration dosage and duration and days until a 20% improvement in LPSS. Observed baseline serum PC levels (bPC) blood concentrations ranged from 31 to 80%. Patients received PC supplementation in case of low age-related bPC levels or >10% PC concentration decrease within 12 hours from the first evaluation. All patients received 80 U/kg/day PC, intravenously, every twenty-four hours. No drug-related adverse event was observed. The observed sepsis-related mortality rate in our cohort was 9%. PC supplementation in our cohort appeared to be safe, and, probably due to prompt PC administration, we observed an overall mortality that was much lower than expected mortality in cancer severe septic patients.
Highlights
Introduction examined data on22 pediatric septic cancer ological isolations were recorded.patients who received PC concentrates in our For each patient, who matched the Protein C (PC) is a vitamin-k dependent ser- Pediatric Oncohematology Unit.Multinational Association of supportive care in ine protease produced by the liver
Baseline e serum PC levels, PC administration dosage m and duration and days until a 20% improvement in Lansky performance status scale (LPSS)
The function Materials and Methods score defined the Hematologic risk score (HRS), that we created in 2007, in order to of activated protein C (APC) as an anticoaguevaluate patients risk for severe sepsis/septic lant is primarily exerted through its ability to We conducted a retrospective study of 22 shock
Summary
30 Stenotrophomonas 4 CR Maltophila in faringeal swab, candida lusitanae in stool. GI yr, years; LPSS, Lansky performance status scale; Microb isol, Microbiological isolation; HRS, Hematologic risk score; R-ALL, Relapsed Acute Lymphoblastic Leukemia; GI, Gastrointestinal; CR, Complete remission from sepsis; ALL, Acute Lymphoblastic Leukemia; MOF, Multiple organ failure; R-AML, Relapsed Acute Myeloid Leukemia; NHL, Non-Hodgkin Lymphoma; AML, Acute Myeloid Leukemia; +, death. Pediatric cancer patients account for administration of APC zymogen among chil- leagues reported cases of acquired PC defiapproximately 3% of all PICU admissions, and dren affected by severe sepsis. O Given these considerations, since 2000, numerous trials (in particular, the PROWESS e study) have been focused on recombinant s human activated APC (rhAPC) supplementau tion, aimed at reducing severe sepsis-related l mortality.[12] given its demonstrated ter study aimed at demonstrating that PC supplementation in purpura fulminans (PF) correlates with a PF improvement and less need of dermatoplasty and amputations.[13] PC supplementation did not cause any bleeding event among the 94 pediatric patients enrolled. Baseline serum protein C levels (bPC), protein C administration dosage and duration and days until a 20% improvement in Lansky performance status scale (LPSS)
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