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Fibrinogen + PCC
This combination replaces depleted fibrinogen and restores multiple clotting factors simultaneously to correct severe coagulopathy and promote hemostasis.
This combination replaces depleted fibrinogen and restores multiple clotting factors simultaneously to correct severe coagulopathy and promote hemostasis. Used for Massive hemorrhage with coagulopathy requiring fibrinogen and factor replacement, Disseminated intravascular coagulation (DIC), Warfarin reversal in life-threatening bleeding.
At a glance
| Generic name | Fibrinogen + PCC |
|---|---|
| Also known as | Fibryga + Octaplex |
| Sponsor | University Health Network, Toronto |
| Drug class | Hemostatic agent / Coagulation factor replacement |
| Modality | Biologic |
| Therapeutic area | Hematology / Critical Care / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
Fibrinogen provides the structural protein substrate for clot formation, while prothrombin complex concentrate (PCC) supplies vitamin K-dependent clotting factors (II, VII, IX, X) to restore the extrinsic and common coagulation pathways. Together, they address both fibrinogen deficiency and factor deficiencies that occur in massive transfusion, disseminated intravascular coagulation, or warfarin reversal scenarios.
Approved indications
- Massive hemorrhage with coagulopathy requiring fibrinogen and factor replacement
- Disseminated intravascular coagulation (DIC)
- Warfarin reversal in life-threatening bleeding
Common side effects
- Thromboembolism (venous thromboembolism, stroke)
- Allergic reaction
- Fever
- Disseminated intravascular coagulation (paradoxical worsening)
Key clinical trials
- Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (PHASE4)
- Assessment of Artificial Intelligence Algorithms for ROTEM
- Point-of-care Management of Coagulopathy in Lung Transplantation
- Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding. (NA)
- Factor In the Initial Resuscitation of Severe Trauma 2 Patients (PHASE4)
- PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding (PHASE4)
- ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery (PHASE2)
- Patient Blood Management for Massive Obstetric Hemorrhage (NA)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fibrinogen + PCC CI brief — competitive landscape report
- Fibrinogen + PCC updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI