Overview
Also known as coagulation factor II, thrombin is a serine protease that plays a physiological role in regulating hemostasis and maintaining blood coagulation. Once converted from prothrombin, thrombin converts fibrinogen to fibrin, which, in combination with platelets from the blood, forms a clot. Medical thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin in the presence of calcium chloride. Thrombin requires no intermediate physiological agent for its action. It clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself. Bovine thrombin however, is capable of causing fatal severe bleeding or thrombosis . This thrombosis may result from the development of antibodies against bovine thrombin . Bleeding may result from the development of antibodies against bovine factor V . These antibodies may subsequently cross-react with endogenous human factor V and lead to its deficiency . Patients who are know or suspected to have antibodies to bovine thrombin and/or bovine factor V should not be re-exposed to the product . Patients who are administered bovine thrombin should be monitored for abnormal coagulation laboratory values, bleeding, or indeed, thrombosis . A variety of human thrombin and recombinant thrombin (ie. thrombin alfa) products are available as alternatives to using bovine thrombin.
Indication
Bovine thrombin is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (like suture, ligature, or cautery) is ineffective or impractical . Additionally, topical bovine thrombin can also be used in combination with an absorbable gelatin sponge, USP .
Associated Conditions
- Refractory to surgical techniques Bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/04/26 | Not Applicable | Not yet recruiting | |||
2024/04/23 | Phase 4 | Recruiting | |||
2021/03/24 | Phase 4 | Terminated | |||
2020/04/22 | Phase 4 | UNKNOWN | |||
2013/07/30 | Phase 2 | Completed | |||
2012/10/30 | Phase 3 | UNKNOWN | National Science Council, Taiwan | ||
2008/12/24 | Not Applicable | Terminated | |||
2005/10/27 | Phase 3 | Completed | |||
2005/09/20 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
BERIPLAST P COMBI-SET 1ML POWDERS AND SOLVENTS FOR SEALANT | SIN16775P | OTHER | 500IU | 5/10/2023 | |
TISSEEL FIBRIN SEALANT VH S/D (FROZEN) | SIN14707P | SOLUTION | 400-625 IU/ml | 12/22/2014 | |
BERIPLAST P COMBI-SET 3ML POWDERS AND SOLVENTS FOR SEALANT | SIN16776P | OTHER | 1500IU | 5/10/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Thrombin | 国药准字H62020504 | 化学药品 | 冻干粉 | 6/22/2020 | |
Thrombin | 国药准字H62020506 | 化学药品 | 冻干粉 | 6/22/2020 | |
Thrombin | 国药准字H53021113 | 化学药品 | 冻干粉 | 9/14/2020 | |
Thrombin | 国药准字H62020505 | 化学药品 | 冻干粉 | 6/22/2020 | |
Thrombin | 国药准字H62020503 | 化学药品 | 冻干粉 | 6/22/2020 | |
Thrombin | 国药准字H36021149 | 化学药品 | 冻干粉 | 7/19/2022 | |
Thrombin | 国药准字H53021112 | 化学药品 | 冻干粉 | 9/14/2020 | |
Lyophilizing Thrombin Powder | 国药准字H36021562 | 化学药品 | 冻干粉 | 7/18/2022 | |
Lyophilizing Thrombin Powder | 国药准字H21024035 | 化学药品 | 散剂 | 6/15/2020 | |
Lyophilizing Thrombin Powder | 国药准字H21024034 | 化学药品 | 散剂 | 6/15/2020 |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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