MedPath

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

Overview

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 .

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

FDA Approved Products

TachoSil
Manufacturer:Baxter Healthcare Corporation
Route:TOPICAL
Strength:2.0 [USP'U] in 1 1
Approved: 2022/04/13
NDC:0338-8701
TachoSil
Manufacturer:Baxter Healthcare Corporation
Route:TOPICAL
Strength:2.0 [USP'U] in 1 1
Approved: 2022/04/13
NDC:0338-8702
TachoSil
Manufacturer:Corza Medical GmbH
Route:TOPICAL
Strength:2.0 [USP'U] in 1 1
Approved: 2023/09/01
NDC:83078-701
TachoSil
Manufacturer:Corza Medical GmbH
Route:TOPICAL
Strength:2.0 [USP'U] in 1 1
Approved: 2023/09/01
NDC:83078-704
TachoSil
Manufacturer:Corza Medical GmbH
Route:TOPICAL
Strength:2.0 [USP'U] in 1 1
Approved: 2023/09/01
NDC:83078-702

Singapore Approved Products

TACHOSIL, MEDICATED SPONGE
Manufacturer:Takeda Austria GmbH, BBF Sterilisation Service GmbH (Sterilisation by Gamma irradiation)
Form:SPONGE
Strength:2.0 IU per sq cm
Online:Yes
Approved: 2013/11/20
Approval:SIN14441P
EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml
Manufacturer:OMRIX biopharmaceuticals Ltd
Form:SOLUTION
Strength:800-1200 IU/ml
Online:Yes
Approved: 2011/02/23
Approval:SIN13921P
VERASEAL SOLUTIONS FOR SEALANT, 80 mg/ml, 500 IU/ml
Manufacturer:Instituto Grifols, S.A.
Form:SOLUTION
Strength:500 IU/ml
Online:Yes
Approved: 2021/04/01
Approval:SIN16143P
ARTISS SOLUTIONS FOR SEALANT, DEEP FROZEN
Manufacturer:Takeda Manufacturing Austria AG (Site: Industriestrasse 72), Takeda Manufacturing Austria AG (Site: Lange Allee 24B), Takeda Manufacturing Austria AG (Site: Lange Allee 24A) (Primary and Secondary Packager)
Form:SOLUTION
Strength:3.2– 5.0 IU/ml
Online:Yes
Approved: 2015/01/06
Approval:SIN14719P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath