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Prothrombin complex
Prothrombin complex concentrate replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore coagulation cascade function.
Prothrombin complex concentrate replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore coagulation cascade function. Used for Warfarin overdose or vitamin K deficiency with bleeding, Urgent reversal of warfarin anticoagulation, Coagulation factor deficiency due to liver disease or disseminated intravascular coagulation.
At a glance
| Generic name | Prothrombin complex |
|---|---|
| Also known as | CONFIDEX |
| Sponsor | IRCCS Policlinico S. Donato |
| Drug class | Vitamin K-dependent clotting factor concentrate |
| Target | Coagulation factors II, VII, IX, X |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Prothrombin complex is a pooled plasma-derived product containing the vitamin K-dependent factors II, VII, IX, and X. It rapidly restores these factors in patients with deficiency due to warfarin overdose, liver disease, or other causes, thereby correcting the prolonged prothrombin time (PT/INR) and restoring hemostatic capacity.
Approved indications
- Warfarin overdose or vitamin K deficiency with bleeding
- Urgent reversal of warfarin anticoagulation
- Coagulation factor deficiency due to liver disease or disseminated intravascular coagulation
Common side effects
- Thromboembolism
- Allergic reaction
- Fever
- Headache
Key clinical trials
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients (NA)
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） (PHASE4)
- Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (NA)
- International Care Bundle Evaluation in Cerebral Hemorrhage Research (PHASE4)
- Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |