Tisseel Duo 500 (Baxter)

Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Fibrin sealant See Correction

1.0 mL, 2.0 mL and 5.0 mL kits, each containing a syringe of sealer protein solution and a syringe of thrombin solution
Approved indication: surgical haemostasis
Australian Medicines Handbook section 7.4

This product is a sealant which can be used as an adjunct to surgical techniques for controlling blood loss. It can also be used as an adjunct in the closure of colostomies.

In addition to fibrinogen, the kits contain vials of thrombin, calcium chloride and a fibrinolysis inhibitor. The fibrinogen is reconstituted with the fibrinolysis inhibitor solution and the thrombin is mixed with the calcium chloride solution. Syringes containing the two mixtures are then loaded into a device which delivers equal volumes of each mixture to the wound. The thrombin converts the fibrinogen to fibrin which seals the wound. It takes two hours for the sealant to reach its full strength, but it reaches 70% strength in 10 minutes. The fibrinolysis inhibitor then stops the fibrin being broken down too quickly. As the preparation can take up to 40 minutes the product is unsuitable for unexpected brisk bleeding.

Topical applications of sealants have been used successfully to reduce bleeding in facial surgery, knee arthroplasty, skin grafting, vascular reconstruction and cardiac surgery. Other studies e.g. of tonsillectomy show no advantage.

There is limited published information on this particular sealant preparation. Its fibrinogen and thrombin components are derived from blood donations so there is a potential for transmitting infection. The fibrinolysis inhibitor has a bovine origin so some patients may have hypersensitivity reactions to cow protein.

A laboratory study compared a range of fibrin tissue adhesives. It found that this product took longer to prepare than a cryoprecipitate from a single donor, but had a greater binding power.1 Although this fibrin sealant could be made up in advance of a procedure, it has to be discarded after four hours. It is also much more expensive than autologous preparations.1



There was an error in the comment about fibrin sealant Tisseel Duo 500. The components of this new presentation of fibrin sealant are contained in preloaded syringes rather than vials. The product only needs to be thawed out before use, so the preparation time can be reduced by warming. After thawing, the product is viable for up to 48, not four, hours.