- Thermogenesis is a company that sells a machine for the production of fibrin sealant of
single donor plasma, the CryoSeal Fibrin Sealant System (CS-1).
- Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate
is the fraction of human plasma that contains concentrated coagulation factors, such as
fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into
fibrin, so that a clot will be formed.
- Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g.
knee- or hip replacement, cosmetical surgery or partial liverresections.
- Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1.
Within Sanquin there is a question whether fibrin sealant can be produced from the
allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied
whether allogenous single donor fibrin sealant produced using the CS-1 is effective in
wound healing and as consequence of this can be registered as a product of Sanquin. To
answer these questions a national working party is formed, working party Fibrin Sealant.
- So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified
by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro
validation has been performed.
- The next step will be a study for the in vivo effectiveness of fibrin sealant produced
of single donor allogeneic quarantaine plasma using the CS-1. As control patients
without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in
Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in
this study. Probably, three more hospitals will participate.
- The use of fibrin sealant will be studied in a prospective randomized trial for patients
undergoing knee and hip replacements.