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
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

Seroma Reduction After Mastectomy

Phase 4
Completed
Conditions
Breast Cancer
Seroma
Aspiration
Interventions
Procedure: Conventional
Procedure: vicryl sutures
First Posted Date
2017-10-10
Last Posted Date
2019-12-03
Lead Sponsor
Zuyderland Medisch Centrum
Target Recruit Count
339
Registration Number
NCT03305757
Locations
🇳🇱

Zuyderland Medisch Centrum, Sittard, Limburg, Netherlands

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

Phase 2
Completed
Conditions
Cerebrospinal Fluid Leaks
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 EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

Phase 3
Completed
Conditions
Controlling Mild to Moderate Bleeding During Surgery
Interventions
First Posted Date
2017-08-21
Last Posted Date
2025-04-27
Lead Sponsor
Ethicon, Inc.
Target Recruit Count
35
Registration Number
NCT03255174
Locations
🇺🇸

University of Alabama Hospital, Birmingham, Alabama, United States

🇺🇸

icahn School of Medicine at Mt Sinai, New York, New York, United States

🇬🇧

Birmingham Chrildren's Hospital, Birmingham, United Kingdom

and more 2 locations

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

Phase 4
Withdrawn
Conditions
Cleft Palate
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

The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP)

Phase 4
Conditions
Cervical Intraepithelial Neoplasia
Cervical Cancer
Interventions
First Posted Date
2015-12-14
Last Posted Date
2017-05-31
Lead Sponsor
Asan Medical Center
Target Recruit Count
268
Registration Number
NCT02629510
Locations
🇰🇷

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of

The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty

Phase 3
Withdrawn
Conditions
Arthroplasty, Replacement, Knee
Interventions
Device: tourniquet
First Posted Date
2015-09-17
Last Posted Date
2018-03-27
Lead Sponsor
Montefiore Medical Center
Registration Number
NCT02553122

Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2014-12-08
Last Posted Date
2019-05-15
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
142
Registration Number
NCT02311543
Locations
🇨🇭

Kantonsspital Aarau, Aarau, Switzerland

🇨🇭

Kantonsspital Baden, Baden, Switzerland

🇨🇭

Kantonsspital Graubünden, Chur, Switzerland

and more 13 locations

A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

Phase 3
Completed
Conditions
Surgical Bleeding
Interventions
Drug: Fibrocaps
First Posted Date
2014-11-05
Last Posted Date
2017-08-16
Lead Sponsor
Mallinckrodt
Target Recruit Count
150
Registration Number
NCT02284256
Locations
🇩🇪

Krankenhaus Nordwest GmbH, Frankfurt am Main, Germany

🇩🇪

Universitaetsklinikum Aachen, RWTH, Aachen, Germany

🇩🇪

Universitätsklinikum Heidelberg, Heidelberg, Germany

and more 12 locations

Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Not Applicable
Completed
Conditions
Esophageal Disease
Gastric Disease
Interventions
First Posted Date
2014-04-07
Last Posted Date
2015-04-24
Lead Sponsor
R. van Hillegersberg
Target Recruit Count
15
Registration Number
NCT02105506
Locations
🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

Not Applicable
Completed
Conditions
Total Knee Replacement
Primary Knee Arthroplasty
Osteoarthritis of the Knee
Interventions
First Posted Date
2013-03-22
Last Posted Date
2013-03-25
Lead Sponsor
University of Milan
Target Recruit Count
62
Registration Number
NCT01816282
Locations
🇮🇹

Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato, San Donato Milanese, Milano, Italy

© Copyright 2025. All Rights Reserved by MedPath