title: Evaluation of an automated system for the collection of packed RBCs, platelets, and plasma.
abstract: BACKGROUND
  This study evaluated the quality of WBC-reduced platelets, RBCs, and plasma collected on a new system (Trima, Gambro BCT) designed to automate the collection of all blood components. The study also evaluated donor safety and suitability of these components for transfusion.
  
  
  METHODS
  In Phase I, the quality of the components collected on the new system was evaluated by standard in vitro and in vivo testing methods. Results were compared to those from control components collected by currently approved standard methods. In Phase II, additional collections were performed to evaluate the acceptability of the new system and the safety of platelets collected.
  
  
  RESULTS
  In vivo 24-hour RBC recovery was 76.8 +/- 3.1 percent for the test RBC units and 77.1 +/- 4.4 percent recovery for whole-blood (control) RBCs. The differences between test and control platelet results in the in vivo and in vitro assays were not clinically significant. Plasma clotting factors and fibrinogen levels met international standards. The system was well accepted by donors, and no major adverse donor reactions were reported for the 68 procedures performed. No problems were reported with transfusing the blood components collected.
  
  
  CONCLUSIONS
  Blood components collected with the Trima are equivalent to currently available components, and they meet the applicable regulatory standards. This system provides consistent, standardized components with predictable yields. It provides the option of fully automating the collection of all blood components.
authors.affiliation: American Red Cross, USA.
authors.forename: M D
authors.initials: MD
authors.lastname: Elfath
authors.forename: P
authors.initials: P
authors.lastname: Whitley
authors.forename: M S
authors.initials: MS
authors.lastname: Jacobson
authors.forename: K
authors.initials: K
authors.lastname: Cranfill-Hupp
authors.forename: D M
authors.initials: DM
authors.lastname: Kemp
authors.forename: D
authors.initials: D
authors.lastname: McNeil
authors.forename: S
authors.initials: S
authors.lastname: Sawyer
authors.forename: S
authors.initials: S
authors.lastname: Bell-Dize
authors.forename: J B
authors.initials: JB
authors.lastname: Gorlin
authors.forename: S V
authors.initials: SV
authors.lastname: Kevy
authors.forename: M J
authors.initials: MJ
authors.lastname: McAteer
mesh_terms: D000328:Adult; D001331:Automation; D016913:Blood Component Transfusion / Q000009:adverse effects; D001792:Blood Platelets; D001800:Blood Specimen Collection / Q000379:methods* / Q000592:standards*; D017707:Erythrocyte Transfusion / Q000009:adverse effects; D004912:Erythrocytes; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D010949:Plasma; D017713:Platelet Transfusion / Q000009:adverse effects