Human thrombin

Generic Name
Human thrombin
Brand Names
Artiss, Evarrest, Evicel, Evithrom, Tachosil, Tisseel, Vistaseal
Drug Type
Biotech
Chemical Formula
-
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

PEP on a Skin Graft Donor Site Wound

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-12-11
Last Posted Date
2023-09-08
Lead Sponsor
Rion Inc.
Target Recruit Count
8
Registration Number
NCT04664738
Locations
🇺🇸

International Research Partners, Doral, Florida, United States

🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Tisseel® as a Reinforcement of Esophagojejunal Anastomoses

First Posted Date
2018-11-07
Last Posted Date
2020-07-23
Lead Sponsor
Germans Trias i Pujol Hospital
Target Recruit Count
146
Registration Number
NCT03733639
Locations
🇪🇸

Elisenda Garsot Savall, Badalona, Barcelona, Spain

Reducing Blood Loss Using Tisseel in TKA

First Posted Date
2017-10-16
Last Posted Date
2017-10-16
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
100
Registration Number
NCT03310060

A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-09-08
Last Posted Date
2021-06-18
Lead Sponsor
Duke University
Target Recruit Count
15
Registration Number
NCT03276975
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2016-11-02
Last Posted Date
2022-05-20
Lead Sponsor
University of Alberta
Registration Number
NCT02953145
Locations
🇨🇦

Stollery Alberta Children's hospital, Edmonton, Alberta, Canada

Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-06-07
Last Posted Date
2020-07-14
Lead Sponsor
Centre Hospitalier Universitaire, Amiens
Target Recruit Count
597
Registration Number
NCT01613664
Locations
🇫🇷

North Universitary Hospital, Amiens, France

🇫🇷

Charles Nicolle Universitary Hospital, Rouen, France

A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery

First Posted Date
2005-09-20
Last Posted Date
2007-08-28
Lead Sponsor
Ethicon, Inc.
Target Recruit Count
304
Registration Number
NCT00196534
Locations
🇺🇸

Union Memorial Hospital, Baltimore, Maryland, United States

🇺🇸

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Northwest NeuroSpecialists, PPLC, Tucson, Arizona, United States

and more 14 locations
© Copyright 2024. All Rights Reserved by MedPath