Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study.

ABSTRACT: Background: Octaplas is a solvent/detergent-treated, pooled plasma used for the management of preoperative or bleeding patients who require replacement of single or multiple coagulation factors. The aim of this post-marketing study was to collect real-world data on octaplas treatment in pediatric patients, with the primary focus being safety. Methods: This was an open-label, multicenter, phase IV study conducted in patients <16 years old who required replacement of multiple coagulation factors due to liver dysfunction associated with coagulopathy and/or required cardiac surgery or liver surgery. Octaplas was administered intravenously based on ABO-group compatibility. The primary endpoints included the incidence of serious adverse events (SAEs), adverse drug reactions (ADRs),

SUBMITTER: Spinella PC 

PROVIDER: S-EPMC7527419 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature