Randomized clinical trial for Fibrin Sealant in knee surgery

• 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 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 that is
also effective in the patient 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
reducing the amount of fluid in the drains post-operative and as consequence of
this can be registered as a product of Sanquin.
• Allogenous quarantain plasma is plasma derived from voluntairy unpaid donors.
The plasma will be released only when two sets of tests with negative test
results. The first tests are imediately after donation, the second series of
tests is after 6 months when donor is tested again.

• To study the effectiveness of fibrin sealant produced of single donor
allogeneic plasma when used intra-operatively after total knee replacement.
o Primairy endpoint: total volume of fluid in the drains at 6h post-operative.
o Secondary endpoints: total volume of fluid in the drains at 24h
post-operative, amount of blood transfused, size of the knee, amount of pain
and mobility (quality of life) after surgery, length of stay in hospital,
adverse events, satisfaction with fibrin sealant as used by the physician.

• The study is a randomized prospective clinical trial.
• Fibrin sealant treated patients will be compared with non fibrin sealant
treated patients.
• Patients included undergo total knee replacement.
• During participation of the patient, only the study coordinator of the
hospital and the staff of the operation room know whether a patient is treated
with fibrin sealant or not.
• Nurses and patients can be informed at the end of participation of the
patient (about six weeks after discharge of the hospital).

Surgery will be performed as usual. Only just before wound closure the fibrin
sealant will be spayed over the wound surface.

nihil to very low additional risks