aprotinin + calcium chloride + human fibrinogen + human thrombin at a glance
Medicine class
Local haemostatic and tissue adhesive.
Administration
Applied topically by a trained, experienced surgeon; it must not be injected into blood vessels.
Presentation
Two solutions in a single-use, double-chamber prefilled syringe; they mix during application.
Human plasma components
The fibrinogen and thrombin components are made from human plasma.
What is aprotinin + calcium chloride + human fibrinogen + human thrombin used for?
Licensed as supportive treatment when standard surgical techniques are insufficient.
Improving haemostasis during surgery.
Promoting tissue adhesion or sealing, or supporting sutures, in gastrointestinal anastomoses.
Promoting sealing or supporting sutures in neurosurgery where the dura or cerebrospinal fluid may be involved.
Fixing mesh during hernia repair as an alternative or addition to sutures or staples.
How does aprotinin + calcium chloride + human fibrinogen + human thrombin work?
Thrombin converts fibrinogen into fibrin, while calcium supports cross-linking that stabilises the resulting clot. Aprotinin slows premature breakdown of fibrin, allowing the seal to persist while healing begins. The material is subsequently cleared through the same processes that remove the body's own fibrin.
How to take aprotinin + calcium chloride + human fibrinogen + human thrombin
This product is not self-administered or swallowed. A trained surgeon applies the mixed solutions directly to a prepared, visible surgical surface using the approved applicator; injection into tissue or blood vessels must be avoided.
The wound surface is dried using standard surgical techniques before application.
The frozen syringe must be completely thawed and appropriately warmed without microwaving or overheating.
Areas outside the intended site are covered to prevent unwanted tissue adhesion.
Spray application requires specified equipment, safe pressure and distance, with physiological monitoring because of the risk of air or gas embolism.
aprotinin + calcium chloride + human fibrinogen + human thrombin side effects
Common or expected effects
- Fluid collection near the operated area (seroma)
- Postoperative wound infection
- Pain, including limb pain
- Raised temperature
- Rash
- Altered sensation
Get urgent medical advice
- Severe allergic or anaphylactic reaction, including breathing difficulty, facial or throat swelling, low blood pressure or shock
- A blood clot or embolism if material enters a blood vessel
- Life-threatening air or gas embolism associated with incorrect spray-device use
- Compression of nearby structures when sealant is applied within a confined space
aprotinin + calcium chloride + human fibrinogen + human thrombin in pregnancy
Controlled pregnancy safety data are unavailable, so use during pregnancy should be limited to situations where it is clearly needed. Because fibrinogen and thrombin come from human plasma, there is a residual risk of transmissible infection, including particular concern from parvovirus B19 during pregnancy.
aprotinin + calcium chloride + human fibrinogen + human thrombin while breastfeeding
Safety during breastfeeding has not been established in controlled trials. The surgical team should use it only when clearly needed after considering the procedure and available alternatives.
aprotinin + calcium chloride + human fibrinogen + human thrombin interactions
Formal interaction studies have not been performed; the most important issues are local incompatibilities at the application site.
Alcohol-, iodine- or heavy-metal-containing antiseptics
Residues may denature the protein components and reduce sealant performance, so they should be removed as far as possible before application.
Oxidised cellulose preparations
These may reduce the sealant's effectiveness and should not be used as carrier materials.
Other medicinal products
The sealant must not be mixed directly with other medicinal products.
Common questions about aprotinin + calcium chloride + human fibrinogen + human thrombin
Answers are fully visible for fast scanning and source review.
What is TISSEEL used for during surgery?
It is used alongside standard surgical methods to improve haemostasis, seal or adhere tissues, support sutures in specified gastrointestinal and neurosurgical procedures, and fix hernia mesh.
Is TISSEEL the same as ordinary skin glue?
No. It is a fibrin sealant for selected surgical uses and is not licensed to replace skin sutures used to close an operation wound.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.