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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

A Phase III Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

Phase 3
Not yet recruiting
Conditions
Hemorrhage
Interventions
Biological: Surgicel Original
First Posted Date
2024-10-30
Last Posted Date
2024-10-30
Lead Sponsor
Corza Medical GmbH
Target Recruit Count
116
Registration Number
NCT06664775

Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial

Phase 4
Recruiting
Conditions
Liver Transplant; Complications
Interventions
First Posted Date
2023-11-09
Last Posted Date
2024-02-28
Lead Sponsor
Medical University of Warsaw
Target Recruit Count
170
Registration Number
NCT06124209
Locations
🇵🇱

Department of General Transplant and Liver Surgery, Warsaw, Mazovian Voivodeship, Poland

Observational Pilot Study With TachoSil as a Ventricular Sealant

Completed
Conditions
Intraventricular Neoplasm
Interventions
First Posted Date
2023-02-08
Last Posted Date
2023-02-08
Lead Sponsor
Germans Trias i Pujol Hospital
Target Recruit Count
20
Registration Number
NCT05717335
Locations
🇪🇸

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

Sensory Recovery of Digital Nerves After Microsurgical Epineural Neurorrhaphy Alone or in Combination With Tisseel - RET

Not Applicable
Not yet recruiting
Conditions
Digital Nerve Injuries
Interventions
First Posted Date
2022-08-08
Last Posted Date
2023-03-03
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
74
Registration Number
NCT05490940
Locations
🇨🇭

Insel Gruppe AG, Bern, Switzerland

GATT-Patch Versus TachoSil in Liver Surgery

Not Applicable
Completed
Conditions
Hemorrhage, Surgical
Liver Diseases
Intraoperative Bleeding
Interventions
Device: GATT-Patch
First Posted Date
2022-05-23
Last Posted Date
2025-03-14
Lead Sponsor
GATT Technologies BV
Target Recruit Count
131
Registration Number
NCT05385952
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

Washington University, Saint Louis, Missouri, United States

🇺🇸

Atrium Health, Charlotte, North Carolina, United States

and more 7 locations

Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears

Phase 2
Withdrawn
Conditions
Rotator Cuff Tears
Interventions
Biological: Stromal Vascular Fraction Cells
First Posted Date
2022-03-03
Last Posted Date
2023-02-15
Lead Sponsor
AdventHealth
Registration Number
NCT05264922
Locations
🇺🇸

AdventHealth Orlando, Orlando, Florida, United States

ARTISS a Single-centre Randomised Control Study

Phase 4
Completed
Conditions
Breast Neoplasms
Mammaplasty
Interventions
First Posted Date
2021-06-18
Last Posted Date
2024-03-13
Lead Sponsor
Mid and South Essex NHS Foundation Trust
Target Recruit Count
135
Registration Number
NCT04931615
Locations
🇬🇧

Mid and South Essex NHS Foundation Trust, Broomfield, Essex, United Kingdom

PEP on a Skin Graft Donor Site Wound

Phase 1
Active, not recruiting
Conditions
Skin Graft
Interventions
Biological: 10% PEP
Biological: 20% PEP
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

Phase 4
Conditions
Gastric Cancer
Anastomotic Leak
Interventions
Device: No Tisseel
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

Phase 4
Conditions
Total Blood Loss
Interventions
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
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