2025 Guidelines for the Evaluation and Management of Adults With Congenital Heart Disease
December 19, 2025
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Brand Name :
Evicel, Tisseel VH, Artiss, TachoSil
Synonyms :
fibrin sealant
Class :
Hemostatics, Wound Care
Brand Name :
Evicel, Tisseel VH, Artiss, TachoSil
Synonyms :
fibrin sealant
Class :
Hemostatics, Wound Care
Dosage Forms & Strengths
Kit
55 to 85 mg/ml fibrinogen and 800 units/ml thrombin
67 to 106 mg/ml fibrinogen and 2.5 to 6.5 units/ml thrombin
67 to 106 mg/ml fibrinogen and 400 to 625 units/ml thrombin
Patch
3.6 to 7.4 mg/cm² fibrinogen and 1.3 to 2.7 units/cm²
For Evicel
Spray onto the surface of bleeding tissues in brief bursts about 0.1 to 0.2 ml and if the hemostatic outcome is incomplete then apply a another coat
If the maximum area to be sealed is 20 cm², then use around 2 ml
If the maximum area to be sealed is 40 cm², then use around 4 ml
If the maximum area to be sealed is 100 cm², then use around 10 ml
For TachoSil Patch
If not more than 7 patches are to be applied, then apply patch size of about 9.5 cm x 4.8 cm
If not more than 14 patches are to be applied, then apply patch size of about 4.8 cm x 4.8 cm
If not more than 42 patches are to be applied, then apply patch size of about 3.0 cm x 2.5 cm
For Tisseel VH
If the maximum area to be sealed is 8 cm² through a cannula then use around 2 ml
If the maximum area to be sealed is 16 cm² through a cannula then use around 4 ml
If the maximum area to be sealed is 40 cm² through a cannula then use around 10 ml
Autologous Skin Graft Adherence
If the graft fixation area is 100 cm², then use around 2 ml
If the graft fixation area is 200 cm², then use around 4 ml
If the graft fixation area is 500 cm², then use around 10 ml
Dosage Forms & Strengths
Kit
55 to 85 mg/ml fibrinogen and 800 units/ml thrombin
67 to 106 mg/ml fibrinogen and 2.5 to 6.5 units/ml thrombin
67 to 106 mg/ml fibrinogen and 400 to 625 units/ml thrombin
For Evicel
Safety and efficacy not determined in less than six years old
≥6 months:
Spray onto the surface of bleeding tissues in brief bursts about 0.1 to 0.2 ml and if the hemostatic outcome is incomplete then apply a another coat
If the maximum area to be sealed is 20 cm², then use around 2 ml
If the maximum area to be sealed is 20 cm², then use around 2 ml
If the maximum area to be sealed is 40 cm², then use around 4 ml
If the maximum area to be sealed is 100 cm², then use around 10 ml
For Tisseel
For <1 month: Safety and efficacy not determined
For ≥1 month:
If the maximum area to be sealed is 8 cm² through a cannula then use around 2 ml
If the maximum area to be sealed is 16 cm² through a cannula then use around 4 ml
If the maximum area to be sealed is 40 cm² through a cannula then use around 10 ml
Autologous Skin Graft Adherence
Safety and efficacy not determined in less than one year old
If the graft fixation area is 100 cm², then use around 2 ml
If the graft fixation area is 200 cm², then use around 4 ml
If the graft fixation area is 500 cm², then use around 10 ml
Refer to adult dosing
Actions and Spectrum
fibrin sealant is generally composed of two main components like fibrinogen and thrombin. When these components are mixed, they initiate a cascade of biochemical reactions that result in the formation of a fibrin clot.
Frequency not defined
Pruritus
Abdominal pain
Anemia
Pleural effusion
Increased serum fibrinogen
Atrial fibrillation
Hematoma
Postoperative hemorrhage
Graft complications
Ascites
Nervous system: Headache
Deep vein thrombosis
Antibody development
Pulmonary embolism
Gastrointestinal hemorrhage
Abdominal distension
Ischemic bowel disease
Abscess
Peritoneal effusion
Post marketing reports
Hematologic and oncologic: Eosinophilia
Hypersensitivity: Anaphylactic shock, anaphylaxis, nonimmune anaphylaxis, angioedema, hypersensitivity reaction
Respiratory: Bronchospasm, respiratory distress, dyspnea, hemothorax, laryngeal edema, wheezing
Cardiovascular: Bradycardia, tachycardia, thrombosis, embolism, flushing, hypotension,
Dermatologic: Erythema of skin, urticaria
Gastrointestinal: Intestinal obstruction, gastrointestinal scarring
Nervous system: Cerebral artery embolism, paresthesia, nerve compression
Renal: Renal artery thrombosis, renal failure syndrome
Black Box Warning
None
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy consideration:
Pregnancy category: C
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
fibrinogen is a protein found in the blood plasma. It is synthesized in the liver and circulates in an inactive form.
The formed fibrin clot adheres to the surrounding tissues, providing a mechanical barrier and promoting hemostasis by stopping bleeding.
Pharmacodynamics
fibrin sealant promotes hemostasis by forming a fibrin clot at the site of application.
fibrin sealant acts as a tissue adhesive, facilitating the adhesion and bonding of biological tissues.
Pharmacokinetics
Limited information available on ADME
Administration
fibrin sealant is administered topically or locally at the site of application. e.g., surgical wounds.
Patient information leaflet
Generic Name: fibrin sealant
Why do we use fibrin sealant?
fibrin sealant acts as a tissue adhesive, helping to bond and secure tissues together.
fibrin sealant is used to promote hemostasis i.e., stop bleeding in surgical procedures or traumatic injuries.
fibrin sealant is used to support tissue grafts and flaps in reconstructive surgeries.
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