Tisseel Vhsd (Aprotinin, Syn) (thrombin(hum plas)/fibrinogen/aprotinin,syn/calcium chloride)

Fibrin sealant, a combination of 2 components (sealer protein concentrate (human) and thrombin (human)) derived from pooled human plasma, mimics the final stage of the blood coagulation cascade.

Thrombin (human), a preparation of human plasma-derived thrombin, is a topical hemostatic agent.

Fibrin sealant consists of 2 components (sealer protein (human) and thrombin (human)) derived from pooled human plasma. When combined, the 2 components mimic the final stage of the blood coagulation cascade. The active ingredient in sealer protein is fibrinogen; sealer protein is available as a freeze-dried powder (in a kit) for reconstitution with fibrinolysis inhibitor solution or as a frozen solution prefilled into one side of a dual-chambered syringe.

Each mL of reconstituted or frozen sealer protein solution contains 96-125 mg of total protein, 67-106 mg of fibrinogen, and 2250-3750 kallikrein inactivator units (KIU) of fibrinolysis inhibitor; other ingredients include human albumin, trisodium citrate, histidine, niacinamide, polysorbate 80, and water for injection. The fibrinolysis inhibitor solution contains aprotinin, a polyvalent protease inhibitor that prevents premature degradation of fibrin and delays fibrinolysis. (See Cautions: Contraindications.) Thrombin, a highly specific protease that transforms the fibrinogen contained in sealer protein into fibrin, is available as a freeze-dried powder for reconstitution with calcium chloride solution (in the kit) or as a frozen liquid solution prefilled into one side of the dual-chambered syringe. Each mL of reconstituted or frozen thrombin solution contains 2.5-6.5 international units (IU) of thrombin and 36-44 mcmol of calcium chloride; other ingredients include human albumin, sodium chloride, and water for injection.

Upon combination of sealer protein and thrombin, soluble fibrinogen is transformed into fibrin, which adheres to the burn wound surface and the skin graft to be affixed. The low thrombin concentration present in the combined product results in a 60-second period before polymerization occurs, providing time for the clinician to manipulate and position the skin graft on the surgically prepared wound bed. Fibrin sealant is applied only topically; systemic exposure or distribution to other organs and tissues is not expected.

Thrombin (human) is a highly purified preparation of thrombin derived from pooled human plasma. Thrombin is prepared from its precursor, prothrombin, through a series of separation and purification steps followed by activation with calcium chloride. Manufacturing pools and individual units of plasma used in the preparation of thrombin (human) are screened for human viruses (e.g., hepatitis, HIV, parvovirus B19).

Additional viral inactivation and purification steps (e.g., solvent/detergent, nanofiltration) are employed to further reduce the risk of pathogen transmission.

Thrombin promotes hemostasis principally by converting fibrinogen to fibrin, the final step in the coagulation cascade. However, thrombin's effects in hemostasis are complex and include several other mechanisms (e.g., platelet activation and aggregation, activation of factor XIII leading to fibrin crosslinking and clot stabilization). Thrombin is capable of converting fibrinogen directly to fibrin at the site of vessel injury without the addition of other substances, thus providing a rationale for its use as a topical hemostatic agent.

Failure of thrombin to clot blood occurs in the rare instance when the primary clotting defect is the absence of fibrinogen. The rate at which thrombin clots blood depends on the concentration of thrombin and fibrinogen.

Thrombin (human) is stable for up to 2 years when stored at -18degreesC or colder. Unopened vials may be stored under refrigeration (2-8degreesC) for up to 30 days or up to the manufacturer's labeled expiration date, whichever comes first.

Generic name: thrombin(hum plas)/fibrinogen/aprotinin,syn/calcium chloride
Drug class: Topical Hemostatics
Therapeutic class: Dermatological

The following indications are listed for Tisseel Vhsd (Aprotinin, Syn):

• Surgical Hemostasis Adjunct