Examples of Fibrin Glue Products
Fibrin glue products available include VistaSeal (Ethicon), Tisseel (Baxter/Immuno), Beriplast P, Evicel, Quixil, Crosseal, Reliseal, Bolheal, Tachosil, Vivostat, Vitagel, and Artiss. 1, 2, 3
FDA-Approved Products
VistaSeal (Ethicon)
- Contains human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL) in a 2 mL dual-syringe system 1
- Supplied as frozen solutions that must be stored at -18°C (0°F) or colder 1
- After thawing, can be stored for up to 7 days at 2-8°C or 24 hours at room temperature if sealed 1
- Comes with dual applicator and airless spray tips for topical application 1
- For topical use only - never inject 1
Tisseel (Baxter Healthcare/Immuno)
- Most extensively studied fibrin sealant in published literature 2, 3
- Heat-treated formulation prepared from pooled plasma 4
- Contains fibrinogen, factor XIII, thrombin, aprotinin (antifibrinolytic), and calcium chloride 3
- Available in Europe and on named-patient basis in UK 4
Other Commercial Products
Additional Formulations
- Beriplast P, Evicel, Quixil, Crosseal, Reliseal, Bolheal, Tachosil, Vivostat, Vitagel, and Artiss are other commercially available fibrin sealants used in cardiovascular and other surgical procedures 2, 3
Composition and Mechanism
Standard Components
- Two-component system: fibrinogen solution mixed with thrombin and calcium chloride 5, 4
- Mimics the final stages of the coagulation cascade to form a fibrin clot 5, 4
- Fibrinogen typically obtained from pooled, single-donor, or autologous blood through cryoprecipitation 5, 4
- Thrombin component generally derived from commercial bovine sources 5, 4
Optional Additives
- Some formulations include calcium chloride and antifibrinolytics (aminocaproic acid or aprotinin) 5, 3
- The resultant clot is completely absorbed during wound healing without foreign body reaction 4
Clinical Applications
Surgical Uses
- Particularly effective in heparinized patients undergoing cardiovascular procedures with extracorporeal circulation, as it does not require an intact hemostatic system 5
- Used for hemostasis and tissue sealing in virtually every surgical specialty 4
- Well-documented effectiveness in cardiovascular surgery, ENT, and neurosurgery 4, 2
- Effective for presealing woven or knitted Dacron vascular grafts 5
Important Limitations
- Fibrin glues are ineffective for massive bleeding because the fibrin clot may be washed away by blood flow 6
- Most appropriate for prevention of re-bleeding rather than arrest of active massive hemorrhage 6
- Requires direct application at the bleeding site 6
Safety Considerations
Infection Risk
- Major drawback is risk of transmitted serological disease from pooled and single-donor blood products 5
- Safest preparations use autologous blood from the patient 5, 4
- VistaSeal carries warnings about potential transmission of infectious agents including viruses, vCJD, and theoretically CJD 1
Hypersensitivity
- Patients should be monitored for hypersensitivity reactions including itching, rash, hives, or breathing problems 1