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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

Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Phase 2
Completed
Conditions
Osteoarthritis
Intraoperative Bleeding
Interventions
First Posted Date
2012-08-03
Last Posted Date
2016-02-09
Lead Sponsor
Rush University Medical Center
Target Recruit Count
73
Registration Number
NCT01656759
Locations
🇺🇸

Rush Oak Park Hospital, Oak Park, Illinois, United States

Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Phase 3
Completed
Conditions
Morbid Obesity
Interventions
Other: no tisseel
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

Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

Phase 3
Completed
Conditions
Bleeding
Interventions
Drug: Surgicel® Original
First Posted Date
2011-12-26
Last Posted Date
2017-02-08
Lead Sponsor
Takeda
Target Recruit Count
150
Registration Number
NCT01500135
Locations
🇺🇸

Nycomed Investigational Site, Bellevue, Washington, United States

Tachosil for the Prevention of Symptomatic Lymph Cysts

Phase 3
Completed
Conditions
Endometrial Cancer
Cervical Cancer
Interventions
First Posted Date
2011-11-11
Last Posted Date
2022-07-08
Lead Sponsor
Ruhr University of Bochum
Target Recruit Count
220
Registration Number
NCT01470677
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

🇩🇪

Ruhr University Bochum, Bochum, Germany

The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Phase 4
Completed
Conditions
Osteoarthritis
Interventions
First Posted Date
2010-11-05
Last Posted Date
2013-10-29
Lead Sponsor
Hospital for Special Surgery, New York
Target Recruit Count
200
Registration Number
NCT01235715
Locations
🇺🇸

Hospital for Special Surgery, New York, New York, United States

A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

Not Applicable
Completed
Conditions
Goiter
Thyroid Neoplasm
Interventions
First Posted Date
2010-10-22
Last Posted Date
2019-02-05
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
55
Registration Number
NCT01226914

Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection

Phase 4
Completed
Conditions
Hemostasis
Liver Surgery
Interventions
Device: Sangustop
First Posted Date
2009-06-11
Last Posted Date
2015-05-28
Lead Sponsor
Aesculap AG
Target Recruit Count
128
Registration Number
NCT00918619
Locations
🇦🇹

Universitätsklinik für Chirurgie, Medizinische Universität Graz, Graz, Austria

🇩🇪

Charité Campus Virchow, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Berlin, Germany

🇩🇪

Klinikum Großhadern, Ludwig-Maximilians-Universität, München, Germany

and more 5 locations

Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Phase 4
Completed
Conditions
Incisional Hernia
Interventions
Procedure: Drainage
First Posted Date
2008-10-17
Last Posted Date
2018-06-26
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
57
Registration Number
NCT00775034
Locations
🇧🇪

University Hospital Ghent, Ghent, Belgium

🇧🇪

UZ gasthuisberg Leuven, Leuven, Belgium

Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

Phase 2
Completed
Conditions
Colorectal Anastomosis
Interventions
First Posted Date
2008-07-11
Last Posted Date
2012-05-08
Lead Sponsor
Nycomed
Target Recruit Count
25
Registration Number
NCT00713661
Locations
🇬🇧

Investigational site, Dartford, Kent, United Kingdom

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

Phase 3
Completed
Conditions
Cardiovascular, Neurologic (Spine), and General 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
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