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Fresh Frozen Plasma (FFP)
Fresh Frozen Plasma replaces deficient clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive bleeding.
Fresh Frozen Plasma replaces deficient clotting factors and other plasma proteins to restore hemostatic function in patients with coagulopathy or massive bleeding. Used for Coagulopathy due to multiple clotting factor deficiencies, Massive transfusion and dilutional coagulopathy, Reversal of warfarin in emergency settings (when prothrombin complex concentrate unavailable).
At a glance
| Generic name | Fresh Frozen Plasma (FFP) |
|---|---|
| Sponsor | Vascular Solutions LLC |
| Drug class | Blood product / Plasma derivative |
| Modality | Biologic |
| Therapeutic area | Hematology / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
FFP is a blood product containing all vitamin K-dependent clotting factors (II, V, VII, X), fibrinogen, and other plasma proteins. It is used to correct multiple factor deficiencies when specific factor replacement is unavailable or impractical, or in cases of massive transfusion where dilutional coagulopathy occurs. FFP restores the ability of blood to clot by providing the missing coagulation cascade components.
Approved indications
- Coagulopathy due to multiple clotting factor deficiencies
- Massive transfusion and dilutional coagulopathy
- Reversal of warfarin in emergency settings (when prothrombin complex concentrate unavailable)
- Thrombotic thrombocytopenic purpura (TTP) plasma exchange
- Deficiency of vitamin K-dependent factors
Common side effects
- Volume overload / Fluid overload
- Transfusion-related acute lung injury (TRALI)
- Allergic reaction
- Transfusion-transmitted infection (rare with modern screening)
- Hyperkalemia
Key clinical trials
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery (PHASE2)
- FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial (PHASE2, PHASE3)
- International Care Bundle Evaluation in Cerebral Hemorrhage Research (PHASE4)
- Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin (PHASE2)
- Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation (NA)
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
- Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (PHASE2)
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:
- Fresh Frozen Plasma (FFP) CI brief — competitive landscape report
- Fresh Frozen Plasma (FFP) updates RSS · CI watch RSS
- Vascular Solutions LLC portfolio CI