Fibrin sealant produced by the CryoSeal FS System: product chemistry, material properties and possible preparation in the autologous preoperative setting.
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.
Buchta
C
C
Department of Blood Group Serology and Transfusion Medicine, Vienna Medical University, Vienna, Austria. christoph.buchta@meduniwien.ac.at
Dettke
M
M
Funovics
P T
PT
Höcker
P
P
Knöbl
P
P
Macher
M
M
Quehenberger
P
P
Treitl
C
C
Worel
N
N
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
D015718:Fibrin Tissue Adhesive; D005353:Fibronectins; D005337:Fibrin; D005340:Fibrinogen; D005176:Factor XIII; D013917:Thrombin