aprotinin + calcium chloride + human fibrinogen + human thrombin: clinical use

Prescribing considerations

• Restrict use to experienced surgeons trained in product preparation and application.
• Use only as an adjunct when standard surgical techniques are insufficient; it does not replace control of brisk arterial or venous bleeding or skin sutures.
• Apply only to the intended topical surface and protect surrounding tissues from unwanted adhesion.
• Carefully assess previous exposure to aprotinin and allergy to bovine proteins because repeat exposure may increase anaphylaxis risk.
• Record the product name and batch number for traceability.
• Paediatric safety and effectiveness have not been established.

Contraindications and cautions

• Intravascular application.
• Known hypersensitivity to any component, including aprotinin.
• Use alone for active or spurting arterial or venous bleeding uncontrolled by conventional techniques.
• Use as a replacement for skin sutures.

Monitoring

• During spray application, monitor blood pressure, pulse, oxygen saturation and end-tidal carbon dioxide for possible air or gas embolism.
• Observe for hypersensitivity; stop application and initiate emergency management at the first sign of a reaction.
• Assess for compressive effects when applied in confined anatomical spaces.
• Ensure the prepared solutions are appropriately thawed, visually acceptable and used with compatible equipment.

Clinical pharmacology

The two-component system reproduces the final stage of coagulation: thrombin converts fibrinogen to fibrin, calcium supports clot stabilisation, and aprotinin inhibits premature fibrinolysis. The solidified sealant is degraded by fibrinolysis and phagocytosis.

Formulation and product differences

• Supplied frozen as two separate solutions within a single-use double-chamber syringe.
• One chamber contains human fibrinogen with synthetic aprotinin; the other contains human thrombin with calcium chloride.
• The components combine in equal volumes through the joining piece and application cannula.
• Available pack volumes differ; not all pack sizes may be marketed.