Version May 2024
Hemostasis, adjunct: Topical: Apply topically in an even, thin layer (do not inject intravascularly); actual dose is based on size of surface to be covered:
TachoSil: Infants ≥1 month, Children, and Adolescents: Apply patch to surface of cardiovascular or hepatic bleeding tissue only. The number of patches applied is determined by the size of the bleeding area. Do not exceed the following maximums:
Patch size: 9.5 cm × 4.8 cm; maximum patches to be applied: 10.
Patch size: 4.8 cm × 4.8 cm; maximum patches to be applied: 14.
Patch size: 3 cm × 2.5 cm; maximum patches to be applied: 42.
Tisseel: Infants >1 month, Children, and Adolescents: Package size to be used is determined by the size of the surface to be covered. Apply in thin layer by dripping or spraying with an approved spray set to completely cover the application area.
|
Size of Tisseel Package |
Maximum Surface Area Coverage | |
|---|---|---|
|
With Spray |
With Cannula | |
|
2 mL |
100 cm2 |
8 cm2 |
|
4 mL |
200 cm2 |
16 cm2 |
|
10 mL |
500 cm2 |
40 cm2 |
Skin graft adherence: Topical:
Artiss: Children ≥1 year and Adolescents: Apply by spraying topically in an even, thin layer over the wound bed immediately prior to applying graft (do not inject intravascularly); actual dose is based on size of surface to be covered:
Approximate graft fixation area: 100 cm2.
Required size of Artiss: 2 mL.
Approximate graft fixation area: 200 cm2.
Required size of Artiss: 4 mL.
Approximate graft fixation area: 500 cm2.
Required size of Artiss: 10 mL.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Fibrin sealant kit: Drug information")
Colonic anastomosis: Tisseel: Package size to be used is determined by the size of the surface to be covered. Apply in a thin layer by dripping or spraying to completely cover the application area.
Maximum area to be sealed: 8 cm2 (cannula application) or 100 cm2 (spray application).
Required package size of Tisseel: 2 mL.
Maximum area to be sealed: 16 cm2 (cannula application) or 200 cm2 (spray application).
Required package size of Tisseel: 4 mL.
Maximum area to be sealed: 40 cm2 (cannula application) or 500 cm2 (spray application).
Required package size of Tisseel: 10 mL.
Hemostasis, adjunct: Apply topically in an even, thin layer (do not inject intravascularly); actual dose is based on size of surface to be covered:
Evarrest: Apply appropriate number of patches as determined by location and surface area; do not use more than four 10.2 cm x 10.2 cm (4 inch x 4 inch) patches or eight 5.1 cm x 10.2 cm (2 inch x 4 inch) patches. If hemostatic effect is not complete due to insufficient area coverage, apply more patches with edges overlapping 1 to 2 cm (0.5 to 1 inch) with the existing patch. If hemostatic effect is not complete due to incomplete adherence to the tissue, remove patch and use a new one.
Evicel [Canadian product]: Spray or drop onto surface of bleeding tissue in short bursts (0.1 to 0.2 mL); if hemostatic effect is not complete, apply a second layer. See product labeling for additional administration details. To cover a layer of 1 mm thickness:
Maximum area to be sealed: 20 cm2.
Required size of Evicel: 2 mL.
Maximum area to be sealed: 40 cm2.
Required size of Evicel: 4 mL.
Maximum area to be sealed: 100 cm2.
Required size of Evicel: 10 mL.
TachoSil: Apply patch to surface of cardiovascular or hepatic tissue only. The number of patches applied is determined by the size of the bleeding area. Do not exceed the following maximums:
Patch size: 9.5 cm x 4.8 cm; maximum patches to be applied: 10.
Patch size: 4.8 cm x 4.8 cm; maximum patches to be applied: 14.
Tisseel: Package size to be used is determined by the size of the surface to be covered. Apply in thin layer by dripping or spraying to completely cover the application area.
Maximum area to be sealed: 8 cm2 (cannula application) or 100 cm2 (spray application).
Required package size of Tisseel: 2 mL.
Maximum area to be sealed: 16 cm2 (cannula application) or 200 cm2 (spray application).
Required package size of Tisseel: 4 mL.
Maximum area to be sealed: 40 cm2 (cannula application) or 500 cm2 (spray application).
Required package size of Tisseel: 10 mL.
Vistaseal: Usual dose ranges from 0.3 mL to 18 mL (dependent on type of surgical intervention, size of area, application method, or number of applications). Package size to be used is determined by the size of the surface to be covered. Apply as a 1 mm thick layer by dripping or spraying to completely cover the application area.
Area to be sealed: 16 cm2 to 22 cm2.
Required package size of Vistaseal: 2 mL.
Area to be sealed: 32 cm2 to 44 cm2.
Required package size of Vistaseal: 4 mL.
Area to be sealed: 48 cm2 to 66 cm2.
Required package size of Vistaseal: 6 mL.
Area to be sealed: 80 cm2 to 110 cm2.
Required package size of Vistaseal: 10 mL.
Skin graft adherence: Artiss: Apply by spraying topically in an even, thin layer over the wound bed immediately prior to applying graft (do not inject intravascularly); actual dose is based on size of surface to be covered:
Approximate graft fixation area: 100 cm2.
Required size of Artiss: 2 mL.
Approximate graft fixation area: 200 cm2.
Required size of Artiss: 4 mL.
Approximate graft fixation area: 500 cm2.
Required size of Artiss: 10 mL.
Facial rhytidectomy (facelift) surgery: Artiss: Adults: Apply by spraying topically in an even, thin layer over the wound bed immediately prior to attaching the skin flap (do not inject intravascularly); actual dose is based on size of surface to be covered:
Approximate graft fixation area: 100 cm2.
Required size of Artiss: 2 mL.
Approximate graft fixation area: 200 cm2.
Required size of Artiss: 4 mL.
Approximate graft fixation area: 500 cm2.
Required size of Artiss: 10 mL.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Adverse reactions may vary by product and indication. Reported adverse reactions are for adults and pediatric patients.
Frequency not defined:
Cardiovascular: Atrial fibrillation, deep vein thrombosis, hypertension, pulmonary embolism
Dermatologic: Pruritus
Gastrointestinal: Abdominal distension, abdominal pain, diarrhea, gastrointestinal hemorrhage, ischemic bowel disease, nausea, peritoneal effusion, vomiting
Hematologic & oncologic: Anemia, hematoma, increased serum fibrinogen, postoperative hemorrhage (including anastomotic and intra-abdominal hemorrhage), prolonged prothrombin time
Hepatic: Ascites, increased serum transaminases (including increased serum alanine aminotransferase, increased serum aspartate aminotransferase)
Immunologic: Antibody development, graft complications (including skin graft failure)
Infection: Abscess (abdominal)
Nervous system: Headache
Respiratory: Pleural effusion
Miscellaneous: Fever, seroma
Postmarketing:
Cardiovascular: Bradycardia, embolism, flushing, hypotension, tachycardia, thrombosis
Dermatologic: Erythema of skin, urticaria
Gastrointestinal: Gastrointestinal scarring (adhesions), intestinal obstruction
Hematologic & oncologic: Eosinophilia
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction, nonimmune anaphylaxis
Local: Local hemorrhage (splenic)
Nervous system: Cerebral artery embolism, nerve compression, paresthesia
Renal: Renal artery thrombosis, renal failure syndrome
Respiratory: Bronchospasm, dyspnea, hemothorax, laryngeal edema, respiratory distress, wheezing
Miscellaneous: Granuloma, inflammation, tissue damage (adhesion), wound healing impairment
Artiss: Hypersensitivity to aprotinin or any component of the formulation (including proteins such as fibrinogen, thrombin, and human albumin); injection directly into the circulatory system or into highly vascularized tissue; use where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Canadian labeling: Additional contraindications (not in US labeling): Treatment of massive brisk arterial or venous bleeding.
Evarrest: Anaphylactic or severe systemic reaction to human blood products; intravascular application; treatment of bleeding from large defects in visible arteries or veins.
Evicel [Canadian product]: Anaphylactic or severe systemic reaction to human blood products; severe or brisk arterial bleeding; direct intravascular injection; for spraying in endoscopic procedures.
TachoSil: Anaphylactic or severe systemic reaction to human blood products or horse protein; intravascular application.
Tisseel: Hypersensitivity to aprotinin or any component of the formulation; direct intravascular injection; severe or brisk arterial or venous bleeding; application where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Vistaseal: Anaphylactic or severe systemic reaction to human blood products; injection directly into the circulatory system; treatment of severe or brisk arterial bleeding; use where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Concerns related to adverse effects:
• Human plasma: Components of fibrin sealant products are made from human plasma and theoretically may potentially transmit disease; viral infections, variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) are potential risks. Any infection suspected of being transmitted by a product should be reported to the manufacturer.
• Hypersensitivity: Cases of hypersensitivity or allergic/anaphylactoid reactions which may progress to severe anaphylaxis have been reported (rarely) with use; risk may increase with repetitive use or with prior systemic aprotinin administration. Discontinue use if symptoms (bradycardia, bronchospasm, dyspnea, erythema, flushing, hypotension, nausea, paresthesia, pruritus, tachycardia, urticaria, wheezing) occur.
Dosage form specific issues:
• Artiss: May contain aprotinin (synthetic source). Not indicated and should not be used for hemostasis.
• Evarrest patch: May cause thrombosis if systemically absorbed. The fewest number of patches should be applied to cover entire bleeding area, portions of excess patch material can become dislodged and migrate to other areas of the body. Do not use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Do not apply to active infections or contaminated areas (risk for infection). Not for use in, around, or in proximity to foramina in bone or areas of bony confine where swelling may cause nerve or blood vessel compression. Use may result in inadvertent adhesion. Not for use in laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve. Do not use to treat bleeding from defects in large arteries or veins where the injured vascular wall requires conventional surgical repair for maintenance of vessel patency or where there would be persistent exposure of fibrin sealant to blood flow and/or pressure during absorption of the product.
• TachoSil patch: May contain collagen, which may adhere to bleeding surfaces. Adhesion to GI tissues leading to GI obstruction have been reported with use during abdominal surgery. Do not apply or leave product in an infected or contaminated space due to potential for infection exacerbation. Do not over-pack when applying product in closed spaces or cavities; may compress underlying tissue. Do not use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Adequately cleanse tissue areas outside the desired application area to prevent tissue adhesions at undesired sites. Use the minimum amount of patches necessary; excess patch material may (theoretically) become dislodged and migrate to other areas of the body. Thrombosis can occur if applied intravascularly; apply only to surface of vascular, cardiac, or hepatic tissue.
• Tisseel: May contain aprotinin (synthetic source). Do not use with oxycellulose-containing preparations; may decrease efficacy. Safety and efficacy in neurologic procedures (or other procedures within a confined space) have not been established.
Other warnings/precautions:
• Administration: For topical use only; do not inject or apply intravascularly; inadvertent intravascular administration may result in serious or life-threatening thromboembolic or allergic/anaphylactoid reaction. Use only the minimum amount necessary; excessive use may decrease efficacy and interfere with wound healing. Air or gas embolism, tissue rupture, or gas entrapment with compression (may be life threatening) has occurred when using spray devices with pressure regulators to apply fibrin sealants; risk of embolism appears to be related to using higher than recommended pressures, administering closer than the recommended distance from tissue surface, or when fibrin sealants are sprayed with air, as compared with CO2. Use only with product-recommended regulators, pressure ranges, and applicator positions. Patches are not for use as substitutes for sutures or any mechanical ligation in major vessel bleeding. Do not use Evarrest or TachoSil patches in children <1 month of age (application is limited due to size).
• Alcohol, iodine, or heavy-metal ions: Exposure to any of these solutions may denature fibrinogen and thrombin proteins; if any were used, thoroughly rinse area before applying fibrin sealant.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit:
Artiss: Solution, topical: Fibrinogen 67-106 mg/mL and thrombin 2.5-6.5 units/mL (2 mL, 4 mL, 10 mL) [contains albumin (human), aprotinin, polysorbate 80; prefilled syringe]
Tisseel: Powder for solution, topical: Fibrinogen 67-106 mg/mL and thrombin 400-625 units/mL (2 mL, 4 mL, 10 mL) [contains albumin (human), aprotinin, polysorbate 80; packaged with reconstituting solutions]
Tisseel: Solution, topical: Fibrinogen 67-106 mg/mL and thrombin 400-625 units/mL (2 mL, 4 mL, 10 mL) [contains albumin (human), aprotinin, polysorbate 80; prefilled syringe]
Vistaseal: Solution, topical: Fibrinogen 80 mg/mL and thrombin 500 units/mL (2 mL, 4 mL, 6 mL, 10 mL) [contains albumin (human); prefilled syringe]
Patch, topical:
Evarrest: Fibrinogen 8.6 mg/cm2 and thrombin 37.5 units/cm2 (1s) [contains albumin (human); 10.2 cm x 10.2 cm]
Evarrest: Fibrinogen 8.6 mg/cm2 and thrombin 37.5 units/cm2 (2s) [contains albumin (human); 5.1 cm x 10.2 cm]
TachoSil: Fibrinogen 3.6-7.4 mg/cm2 and thrombin 1.3-2.7 units/cm2 (1s) [contains albumin (human), collagen (equine); 9.5 cm x 4.8 cm]
TachoSil: Fibrinogen 3.6-7.4 mg/cm2 and thrombin 1.3-2.7 units/cm2 (2s) [contains albumin (human), collagen (equine); 4.8 cm x 4.8 cm]
No
Kit (Artiss External)
2 mL (per mL): $136.42
4 mL (per mL): $116.17
10 mL (per mL): $104.00
Kit (Tisseel External)
2 mL (per each): $202.37
4 mL (per each): $338.76
10 mL (per each): $825.54
Patch (TachoSil External)
4.8 X 4.8 cm (per each): $556.39
9.5 X 4.8 cm (per each): $948.55
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Artiss: Wound surface should be as dry as possible prior to application. Apply using a painting motion in a thin layer to dry wound surface using Easyspray and Spray set (areas covered with fibrin sealant will appear to “glisten”). Immediately attach flap or skin graft; approximate time available for manipulation/positioning is 60 seconds. Hold graft in position with gentle compression for at least 3 minutes; full adherence is achieved in ~2 hours. To prevent sealant from adhering to gloves, wet them with saline prior to contact. The cannulas included with the application system may be used for small wounds or for edges of a skin graft that did not adhere to the wound bed. Immediately before application, expel and discard the first several drops from the application cannula to ensure adequate mixing of the sealer protein and thrombin solutions. Cannulas may become clogged if application is interrupted; replace cannula immediately prior to resuming application; if Y connector is clogged, use provided spare piece.
TachoSil: The outer aluminum foil pouch may be opened in a nonsterile environment; the inner sterile blister must be opened in a sterile environment. Apply the yellow, active side directly to the bleeding tissue (extending 1 to 2 cm beyond margins of wound) either wet or dry. If applied wet, premoisten patch in NS for ≤1 minute, then apply immediately. After applying, hold in place with gentle compression through moistened gloves or moistened pad for at least 3 minutes. To prevent inactive side of patch from adhering to pad or gloves, place a clean surgical instrument at one end of the patch prior to relieving pressure; area may also be moistened with saline solution. Once patch adheres, leave in place. Handle unattached patches with care to either reposition or remove. The application procedure may be repeated if bleeding continues during or after the compression period, but do not remove applied patches. Document product batch number(s) in patient record.
Tisseel: Apply in thin layers (by dripping or spraying using a cannula or spray set) to avoid excess formation of granulation tissue and slow absorption of the sealant. When using a spray device, use the manufacturer's recommended ranges of gas, pressure, and distance from tissue recommended in the manufacturer's labeling. Following application, hold the sealed parts in the desired position for 3 to 5 minutes. If repeat application is necessary, dry the site as much as possible before reapplying. To prevent sealant from adhering to gloves or surgical instruments, wet them with saline prior to contact. In cases where very small volumes (1 to 2 drops) are required, expel and discard the first several drops from the application cannula to ensure adequate mixing of the sealer protein and thrombin solutions. Cannulas may become clogged if application is interrupted; replace cannula immediately prior to resuming application; if Y connector is clogged, use provided spare piece.
Topical:
Artiss: Prior to use, dry application site using standard techniques (eg, intermittent application of compresses, swabs, use of suction devices); do not use pressurized air or gas for drying the site. Apply only to application sites that are visible using a painting motion from side to side in a thin layer to dry wound surface using EasySpray and Spray set or an equivalent device cleared by FDA (areas covered with fibrin sealant will appear to “glisten”); do not use EasySpray and Spray set system in enclosed body cavities. Immediately after spraying fibrin sealant, attach flap or skin graft; approximate time available for manipulation/positioning is 60 seconds. Hold graft in position with gentle compression for at least 3 minutes; full adherence is achieved in ~2 hours. To prevent sealant from adhering to gloves, wet them with saline prior to contact. The cannulas included with the application system may be used for small wounds or for edges of a skin graft that did not adhere to the wound bed. Immediately before application, expel and discard the first several drops from the application cannula to ensure adequate mixing of the sealer protein and thrombin solutions. Cannulas may become clogged if application is interrupted; replace cannula immediately prior to resuming application; if Y connector is clogged, use provided spare piece. The thawed sealer protein solution should be liquid but slightly viscous; do not use if the solution has the consistency of a solidified gel. Refer to manufacturer labeling for detailed instructions for use of AST syringe and PRIMA syringe.
Evarrest: For topical use only; apply to surface of bleeding site only. Prior to applying, remove excess blood or fluid from the site of application to improve visibility. The anatomic location and surface area of the bleeding should be used to determine how many patches should be applied. Patches can be cut to shape and size; ensure an overlap of about 0.5 to 1 inch. The active, powdery side of the patch should be applied to the tissue or prosthetic graft. Immediate, continuous manual compression using dry or moist laparotomy pads or surgical gauze should be applied evenly to the entire surface of the patch and continuous contact pressure should be held for 3 minutes.
Evicel [Canadian product]: For topical use only; apply to surface of bleeding tissue only; do not inject directly into the circulatory system or into tissues. Prior to applying, dry surface areas of wound and remove excess blood from site of application by standard techniques (eg, intermittent application of compresses, swabs, use of suction devices). Refer to manufacturer's labeling for detailed administration instructions.
TachoSil: The outer aluminum foil pouch may be opened in a nonsterile environment; the inner sterile blister must be opened in a sterile environment. Adequately cleanse tissue areas outside the desired application area to prevent tissue adhesions at undesired sites. Apply the yellow, active side directly to the bleeding tissue (extending 1 to 2 cm beyond margins of wound) either wet or dry. If applied wet, premoisten patch in NS for ≤1 minute, then apply immediately. After applying, hold in place with gentle compression through moistened gloves or moistened pad for at least 3 minutes. To prevent inactive side of patch from adhering to pad or gloves, place a clean surgical instrument at one end of the patch prior to relieving pressure; area may also be moistened with saline solution. Once patch adheres, leave in place. Handle unattached patches with care and replace with new patches. The application procedure may be repeated if bleeding continues during or after the compression period, but do not remove applied patches. Document product batch number(s) in patient record.
Tisseel: Apply in thin layers (by dripping or spraying using a cannula or spray set) to avoid excess formation of granulation tissue and slow absorption of the sealant. When using a spray device, use the ranges of gas, pressure, and distance from tissue recommended in the manufacturer's labeling. Following application, hold the sealed parts in the desired position for 3 to 5 minutes. If repeat application is necessary, dry the site as much as possible before reapplying. To prevent sealant from adhering to gloves or surgical instruments, wet them with saline prior to contact. In cases where very small volumes (1 to 2 drops) are required, expel and discard the first several drops from the application cannula to ensure adequate mixing of the sealer protein and thrombin solutions. Cannulas may become clogged if application is interrupted; replace cannula immediately prior to resuming application; if Y connector is clogged, use provided spare piece.
Vistaseal: For topical use only. Prior to use, dry application site using standard techniques (eg, intermittent application of compresses, swabs, use of suction devices); cover body parts outside of application area to prevent undesired tissue adhesion. Refer to manufacturer's labeling for connection and transfer instructions.
Application by dripping: Remove airless spray tip portion and drip tip. Bend drip tip to desired position (tip will retain shape); keep tip of applicator as close as possible to the tissue surface without touching during application. Apply individual drops to surface area to be treated; allow drops to separate from each other and end of drip tip to prevent uncontrolled clotting. Avoid reconnecting a used drip tip; a clot may form and cause the applicator to be unusable.
Application by spraying: Bend dual applicator to desired position (tip will retain shape). Position airless spray tip at least 2 cm away from the target tissue and apply firm even pressure to the plunger; increase distance accordingly to achieve desired coverage of target area. If spray is interrupted for any reason, airless spray tip must be changed; red indicator will not be visible if airless spray tip is properly connected. Avoid pushing plunger in an attempt to clear the fibrin clot within the airless spray tip. Avoid trimming the dual applicator.
Artiss: Store frozen at or below -20°C (-68°F). Unopened pouches (which have been thawed at room temperature) may be stored for up to 14 days at room temperature (15°C to 25°C [59°F to 77°F]). If removed from original pouch or warmed to 33°C to 37°C (91°F to 98.6°F), use within 12 hours. Do not expose product to temperatures >37°C (>98.6°F). Do not microwave. Do not refrigerate or refreeze. For single use only; discard any unused product. Refer to Artiss manufacturer's labeling for additional thawing instructions.
Evarrest: Store unopened packages at 2°C to 25°C (35°F to 77°F); do not refrigerate; do not freeze. Once opened in the sterile field, keep the patches dry to prevent premature activation of the components. Discard any damaged packages because they cannot be resterilized.
Evicel [Canadian product]: Store vials in an upright position; store frozen at or below -18°C (-64.4°F) for ≤2 years; protect from light. Unopened vials may also be stored at 2°C to 8°C (35°F to 46°F) for up to 30 days and protected from light or up to 24 hours at room temperature. Vials should be thawed prior to use; do not refreeze; if thawed at room temperature, do not re-refrigerate; do not exceed 10 minutes at 37°C (98.6°F). Vials are for single use only; discard any unused product after 24 hours at room temperature.
Tisseel kit, powder for solution: Store intact vials at 2°C to 25°C (35°F to 77°F); do not freeze; do not microwave. Do not refrigerate or freeze after reconstitution.
Tisseel prefilled syringe: Store frozen at or below -20°C (-68°F). Unopened pouches (which have been thawed at room temperature) may be stored for up to 48 hours at room temperature (15°C to 25°C [59°F to 77°F]).
TachoSil patch: Store at 2°C to 25°C (35°F to 77°F); refrigeration not required; do not freeze. The outer aluminum foil pouch may be opened in a nonsterile environment; the inner sterile blister must be opened in a sterile environment. Discard any damaged packages since they cannot be resterilized.
Vistaseal: Store frozen at or below -18°C (-0.4°F) for up to 2 years. Unopened pouches (that have been thawed) may be stored for up to 48 hours under refrigeration at 2°C to 8°C (35°F to 46°F) or 24 hours at room temperature (20°C to 25°C [68°F to 77°F]). Do no refreeze. Protect from light.
Artiss: Aid in adhering autologous skin grafts in burn patients (FDA approved in ages ≥1 year and adults) or tissue flaps during facial rhytidectomy surgery (facelift) (FDA approved in adults).
Evarrest: Adjunct to hemostasis during liver surgery and for soft tissue bleeding in open retroperitoneal, intra-abdominal, pelvic, and noncardiac thoracic surgery when control of bleeding by conventional surgical techniques is ineffective or impractical (FDA approved in adults).
TachoSil: Adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by conventional surgical technique is ineffective or impractical (FDA approved in ages ≥1 month and adults).
Tisseel: Adjunct to hemostasis in surgery (including fully heparinized patients) when the control of bleeding by conventional surgical techniques is ineffective or impractical (FDA approved in ages >1 month and adults); adjunctive sealant for closure of colostomies (FDA approved in adults). Note: Pediatric clinical trials only included data from cardiac and resternotomy patients.
Vistaseal: Adjunct to hemostasis for mild to moderate bleeding in surgery when control of bleeding by conventional surgical techniques is ineffective or impractical (FDA approved in adults).
Serious and fatal air or gas embolisms have occurred during or after fibrin sealant application using air or gas pressurized spray devices, particularly when used improperly. Manufacturer directions should be followed closely to ensure safe use of spray devices.
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted.
Monitor changes in blood pressure, pulse, oxygen saturation, and end-tidal CO2 when spraying (due to the possibility of gas embolism); hypersensitivity reactions; serum potassium
Formation of a biodegradable adhesive is done by duplicating the last step of the coagulation cascade, the formation of fibrin from fibrinogen. Fibrinogen is the main component of the sealant solution. The solution also contains thrombin, which transforms fibrinogen from the sealer protein solution into fibrin, and fibrinolysis inhibitor (aprotinin), which prevents the premature degradation of fibrin. When mixed as directed, a viscous solution forms that sets into an elastic coagulum. Patches contain fibrinogen and thrombin that, in contact with bleeding surfaces, hydrate, form active fibrin, then produce a fibrin clot.
Onset of action: Artiss: Full adherence achieved: ~2 hours.
Time to hemostasis: Evarrest: 4 minutes; Evicel [Canadian product]: 4 to 10 minutes; TachoSil: 3 to 6 minutes; Tisseel: 5 minutes.
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