human fibrinogen + human thrombin: clinical use

Prescribing considerations

• Restricted to trained, experienced surgeons and epilesional use.
• Use only as supportive haemostasis when conventional surgical techniques are insufficient.
• Protect adjacent tissue, dry the target surface and avoid an excessively thick clot.
• Evidence is inadequate for tissue gluing, neurosurgery, flexible-endoscopic haemostasis or gastrointestinal anastomoses.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Intravascular application
• Hypersensitivity to either active component or an excipient
• Severe or brisk arterial bleeding

Monitoring

• Assess local haemostasis and wound integrity.
• Observe for hypersensitivity during and after application.
• Remain alert to thromboembolism if inadvertent intravascular exposure is suspected.
• Report suspected adverse reactions through the MHRA Yellow Card scheme.

Clinical pharmacology

Thrombin cleaves fibrinogen into fibrin monomers, which aggregate and are cross-linked by activated factor XIII in the presence of calcium. The clot is later removed by fibrinolysis and phagocytosis.

Formulation and product differences

• Supplied as two separate frozen, plasma-derived solutions in pre-filled syringes that mix during application.
• The thrombin component also contains human albumin.
• The single-use applicator supports dripping or airless spraying; the product must not be mixed with other medicines.
• Once thawed, it must not be refrozen; opened packs are for immediate use.