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Human thrombin

Generic Name
Human thrombin
Brand Names
Artiss, Evarrest, Evicel, Evithrom, Tachosil, Tisseel, Vistaseal
Drug Type
Biotech
CAS Number
9002-04-4
Unique Ingredient Identifier
6K15ABL77G
Background

Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues.

In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line . Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride .

Indication

Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

In combination with fibrinogen, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Associated Conditions
Bleeding, Suture rupture
Associated Therapies
Myringoplasty, Maintenance of surgical hemostasis therapy

FDA Approves VISTASEAL Fibrin Sealant for Pediatric Surgical Bleeding

• The FDA has approved VISTASEAL, a fibrin sealant from Grifols, for controlling surgical bleeding in pediatric patients. • VISTASEAL combines fibrinogen and thrombin proteins to promote hemostasis and tissue sealing during surgery, reducing blood loss. • A Phase 3b study demonstrated VISTASEAL's efficacy in achieving hemostasis within 4 minutes in over 95% of pediatric patients. • VISTASEAL is contraindicated for intravascular injection or use in patients with anaphylaxis to human blood products.
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