title: Fibrin sealant produced by the CryoSeal FS System: product chemistry, material properties and possible preparation in the autologous preoperative setting.
abstract: OBJECTIVE
  The CryoSeal FS has been introduced as an automated device for the production of fibrin sealant from small volumes of plasma. We tested this device and compared the product with commercially available fibrin sealants and with the requirements of the European Pharmacopoeia.
  
  
  METHODS
  The CP3 program and disposables required were used to manufacture fibrin sealant. The chemistry and mechanical properties of the product were investigated.
  
  
  RESULTS
  The cryoprecipitate generated with CryoSeal contains concentrated fibrinogen and critical clotting factors. The efficiency of the production process is poor, but the production procedure itself is simple and not time-consuming. The volume of plasma required allows application in the preoperative autologous setting.
  
  
  CONCLUSIONS
  The CryoSeal FS is an automated device for cryoprecipitation and production of thrombin. It can be implemented easily in the clinical routine, although, owing to product specifications, the efficacy of the CryoSeal fibrin sealant requires further clinical trials.
authors.affiliation: Department of Blood Group Serology and Transfusion Medicine, Vienna Medical University, Vienna, Austria. christoph.buchta@meduniwien.ac.at
authors.forename: C
authors.initials: C
authors.lastname: Buchta
authors.forename: M
authors.initials: M
authors.lastname: Dettke
authors.forename: P T
authors.initials: PT
authors.lastname: Funovics
authors.forename: P
authors.initials: P
authors.lastname: Höcker
authors.forename: P
authors.initials: P
authors.lastname: Knöbl
authors.forename: M
authors.initials: M
authors.lastname: Macher
authors.forename: P
authors.initials: P
authors.lastname: Quehenberger
authors.forename: C
authors.initials: C
authors.lastname: Treitl
authors.forename: N
authors.initials: N
authors.lastname: Worel
mesh_terms: D001781:Blood Component Removal / Q000295:instrumentation*; D004209:Disposable Equipment; D004548:Elasticity; D004591:Electrophoresis, Polyacrylamide Gel; D004867:Equipment Design; D005176:Factor XIII / Q000032:analysis; D005337:Fibrin / Q000302:isolation & purification*; D015718:Fibrin Tissue Adhesive / Q000737:chemistry / Q000302:isolation & purification*; D005340:Fibrinogen / Q000302:isolation & purification; D005353:Fibronectins / Q000032:analysis / Q000302:isolation & purification; D005590:Fractional Precipitation; D005615:Freezing; D006801:Humans; D008422:Materials Testing; D010949:Plasma; D013916:Thrombelastography; D013917:Thrombin / Q000302:isolation & purification
chemical_list: D015718:Fibrin Tissue Adhesive; D005353:Fibronectins; D005337:Fibrin; D005340:Fibrinogen; D005176:Factor XIII; D013917:Thrombin