FAQ - Vivostat^® Fibrin Sealant

FAQ - Vivostat Fibrin Sealant

• When should I draw the 120 ml blood from the patient?

  We recommend drawing blood up to four hours before surgery.
  
  However, there is nothing in the design or process of the Vivostat® system that prevents you from drawing blood earlier. You can fill the Preparation Unit up to 24 hours before you place it in the Processor Unit.
  
  If the blood is drawn more than three hours before use in the Processor Unit, the Preparation Unit should be kept in the refrigerator at 5 degrees C (do not freeze). In addition, labelling and storage procedures will have to be established.

• Can I draw less than 120 ml blood?

  The system and preparation process are designed based on this specific volume. A reduction in blood volume will reduce the amount of fibrin. At 60 ml blood no fibrin will be produced. The Preparation Unit should therefore always be completely filled with 120 ml of blood.

• Can I use plasma if I cannot draw blood?

  Yes, this is a viable option for paediatric or anaemic patients. We recommend patients should weigh more than 20 kg to draw 120 ml blood.
  
  The Vivostat® system operates in exactly the same way with plasma.There are just a few important things to remember:

  • It must be fresh frozen plasma.
  • You cannot use products such as SAG M or other erythrocyte products. They will not produce any fibrin as the plasma has been removed.

• Can I prepare Vivostat® fibrin sealant from fully heparinised blood?

  Vivostat® fibrin sealant can be prepared from heparinised blood and will perform very well on fully heparinised patients as well as patients on aspirin and warfarin therapy.

• Can I use blood from the heart-lung machine?

  Yes, you can take blood from the heart-lung machine.
  
  To make sure that the priming fluid and blood is fully mixed, we recommend waiting 10 minutes after the patient has been connected to the heart-lung machine before drawing the blood. We also recommend to add 100mg Tranexmic acid to the prep-unit before drawing the blood to prevent fibrinolysis.

  N.B.: Heavy blood flow from the heart lung machine might casue bubbles in the preparation unit..

• For how long can I use Vivostat® fibrin sealant?

  Vivostat^® fibrin sealant can be prepared and used intermittently throughout a lengthy operation without loss of effectiveness.
  
  Studies have shown that storage of Vivostat^® fibrin solution for eight hours at room temperature after preparation has no significant effect on the physical properties of the derived sealant.

• Is 5 ml of fibrin sealant enough?

  Yes, the revolutionary design of both the Spraypen® and the delivery system enables the surgeon to cover an area of up to 60 cm2 from only 5 ml of Vivostat® Fibrin Sealant.

• Are the components in the Vivostat® disposable sets latex free?

  Yes, all disposable components used in the Vivostat^® disposable sets are latex free.

• Is the risk of viral infection real?

  Commercial fibrin sealants based on pooled blood are all treated to avoid any risk and donor blood is throughly tested. However, tests can only be performed for known viruses!
  
  An example is the test for Parvovirus B19, that was only recently introduced by commercial manufacturers. A study in Japan has shown that before this test was implemented, 20% of uninfected patients were subsequently infected with Parvovirus B19 by the use of commercial fibrin sealant during surgery.