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 |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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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 |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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THROMBOSTAT 5000UNITS | 00023094 | Powder For Solution - Topical | 5000 UNIT / VIAL | 12/31/1951 | |
THROMBOSTAT 1000UNITS | parke-davis division, warner-lambert canada inc. | 00023086 | Powder - Topical | 1000 UNIT / VIAL | 12/31/1960 |
THROMBINAR PWS 5000UNIT/VIAL | Armour Pharmaceutical Co. | 00608696 | Powder For Solution - Topical | 5000 UNIT / VIAL | 12/31/1984 |
THROMBOSTAT 10000UNITS | 00023108 | Powder - Topical | 10000 UNIT / VIAL | 12/31/1954 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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