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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/30 | Phase 3 | Not yet recruiting | |||
2023/11/09 | Phase 4 | Recruiting | Medical University of Warsaw | ||
2023/02/08 | N/A | Completed | |||
2022/08/08 | Not Applicable | Not yet recruiting | |||
2022/05/23 | Not Applicable | Completed | |||
2022/03/03 | Phase 2 | Withdrawn | |||
2021/06/18 | Phase 4 | Completed | |||
2020/12/11 | Phase 1 | Active, not recruiting | |||
2018/11/07 | Phase 4 | UNKNOWN | |||
2017/10/16 | Phase 4 | UNKNOWN | Chang Gung Memorial Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Baxter Healthcare Corporation | 0338-8701 | TOPICAL | 2.0 [USP'U] in 1 1 | 4/13/2022 | |
Corza Medical GmbH | 83078-704 | TOPICAL | 2.0 [USP'U] in 1 1 | 9/1/2023 | |
Baxter Healthcare Corporation | 0338-8702 | TOPICAL | 2.0 [USP'U] in 1 1 | 4/13/2022 | |
Baxter Healthcare Corporation | 0338-8704 | TOPICAL | 2.0 [USP'U] in 1 1 | 4/13/2022 | |
Corza Medical GmbH | 83078-701 | TOPICAL | 2.0 [USP'U] in 1 1 | 9/1/2023 | |
Corza Medical GmbH | 83078-702 | TOPICAL | 2.0 [USP'U] in 1 1 | 9/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/8/2004 | ||
Authorised | 6/8/2004 | ||
Withdrawn | 10/5/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
TACHOSIL, MEDICATED SPONGE | SIN14441P | SPONGE | 2.0 IU per sq cm | 11/20/2013 | |
EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml | SIN13921P | SOLUTION | 800-1200 IU/ml | 2/23/2011 | |
VERASEAL SOLUTIONS FOR SEALANT, 80 mg/ml, 500 IU/ml | SIN16143P | SOLUTION | 500 IU/ml | 4/1/2021 | |
ARTISS SOLUTIONS FOR SEALANT, DEEP FROZEN | SIN14719P | SOLUTION | 3.2– 5.0 IU/ml | 1/6/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Human Thrombin for External use,Freeze-dried | 国药准字S20050092 | 生物制品 | 冻干粉 | 5/14/2020 | |
Human Prothrombin Complex | 国药准字S20190034 | 生物制品 | 注射剂 | 4/3/2024 | |
Human Prothrombin Complex | 国药准字S10970049 | 生物制品 | 注射剂(冻干粉针剂) | 4/9/2020 | |
Human Prothrombin Complex | 国药准字S10970050 | 生物制品 | 注射剂(冻干粉针剂) | 4/9/2020 | |
Human Prothrombin Complex | 国药准字S20233101 | 生物制品 | 注射剂 | 2/21/2023 | |
Human Prothrombin Complex | 国药准字S20083058 | 生物制品 | 注射剂 | 5/14/2020 | |
Human Prothrombin Complex | 国药准字S20240021 | 生物制品 | 注射剂 | 5/21/2024 | |
Human Prothrombin Complex | 国药准字S20240045 | 生物制品 | 注射剂 | 9/26/2024 | |
Human Prothrombin Complex | 国药准字S20233102 | 生物制品 | 注射剂 | 2/21/2023 | |
Human Prothrombin Complex | 国药准字S20190035 | 生物制品 | 注射剂 | 4/3/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ARTISS fibrin sealant VH S/D 4 IU (frozen) solution for sealant syringe | 163515 | Medicine | A | 8/19/2010 | |
TISSEEL VH S/D fibrin sealant syringe | 147141 | Medicine | A | 3/13/2009 | |
TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack | 176631 | Medicine | A | 3/22/2012 | |
VeraSeal solutions for sealant 4 mL (Human fibrinogen 80 mg/mL syringe 2 ml / Human thrombin 500 IU/mL syringe 2 ml) | 336835 | Medicine | A | 11/3/2021 | |
VeraSeal solutions for sealant 2 mL (Human fibrinogen 80 mg/mL syringe 1 mL / Human thrombin 500 IU/mL syringe 1 mL) | 335950 | Medicine | A | 11/2/2021 | |
VeraSeal solutions for sealant 6 mL (Human fibrinogen 80 mg/mL syringe 3 ml / Human thrombin 500 IU/mL syringe 3 ml) | 336836 | Medicine | A | 11/3/2021 | |
VeraSeal solutions for sealant 10 mL (Human fibrinogen 80 mg/mL syringe 5 ml / Human thrombin 500 IU/mL syringe 5 ml) | 336837 | Medicine | A | 11/3/2021 |