1. Clinical Overview
A topical hemostatic agent, also known as a fibrin sealant or tissue adhesive, combining bovine-derived aprotinin, human-derived fibrinogen, and bovine-derived thrombin. It mimics the final stage of the coagulation cascade, forming a stable fibrin clot at the site of application. Primarily used in surgical settings to control bleeding where conventional methods are ineffective or impractical.
| Onset | Duration | Bioavailability |
|---|---|---|
| Within 30-60 seconds of application. | The fibrin clot is stable for 10-14 days before being degraded by fibrinolysis. | Not applicable (Topical application). Systemic absorption is minimal and not relevant for therapeutic effect. |
2. Mechanism of Action
The combination mimics the final step of the coagulation cascade. Thrombin (Factor IIa) enzymatically cleaves fibrinogen to form fibrin monomers. These monomers spontaneously polymerize to form a fibrin mesh. Factor XIII (present in plasma and often in the fibrinogen component) is activated by thrombin to cross-link the fibrin polymer, forming a stable, insoluble clot. Aprotinin, a serine protease inhibitor, acts as an antifibrinolytic agent by inhibiting plasmin and kallikrein, thereby protecting the newly formed fibrin clot from premature degradation.
3. Indications & Uses
- Hemostasis in surgery where control of bleeding by conventional surgical techniques is ineffective or impractical (e.g., cardiovascular surgery, liver surgery, splenic trauma).
- Sealing of colonic anastomoses to prevent leakage.
- As an adjunct in skin grafting for fixation of grafts (e.g., mesh grafts).
- Sealing of cerebrospinal fluid leaks in neurosurgery.
4. Dosage & Administration
Adult Dosage: Dosage is not fixed; it depends on the size of the area to be treated. The standard vial composition (3000 KIU Aprotinin + 70mg Fibrinogen + 500 IU Thrombin) is typically sufficient for an area of 4-6 cm². Apply the minimum volume required to achieve hemostasis.
Administration: Supplied as a dual-chamber syringe or separate vials. The fibrinogen/aprotinin solution and thrombin solution are mixed at the time of application using a provided applicator tip. Apply as a thin layer using a spatula, spray, or drip technique directly onto the bleeding surface. Hold in place with gentle pressure for 1-3 minutes. Must be used immediately after reconstitution/mixing.
5. Side Effects
Common side effects may include:
- Local inflammatory reaction at application site.
- Mild fever.
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Antifibrinolytic agents (e.g., Tranexamic acid, Aminocaproic acid) | Additive antifibrinolytic effect. Risk of excessive thrombosis if systemic absorption occurs. | Moderate |
| Anticoagulants (e.g., Heparin, Warfarin) | May reduce the local hemostatic efficacy of the sealant. Systemic anticoagulation overrides local effect. | Major |
| Anti-platelet drugs (e.g., Aspirin, Clopidogrel) | May reduce the efficacy of the fibrin clot by impairing platelet plug integration. | Moderate |
7. Patient Counselling
- Inform your surgeon about any known allergies, especially to beef or bovine products.
- Disclose all medications, especially blood thinners.
- Understand that this is a surgical aid applied by the doctor, not a take-home medication.
8. Toxicology & Storage
Overdose: Topical overdose is unlikely. Theoretical risks from massive application include systemic absorption leading to: nausea, hypotension, tachycardia, allergic reactions, and potential for thromboembolism.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light. Keep in outer carton. The reconstituted/mixed product must be used immediately and cannot be stored. Check expiry date before use.