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FFP/Cryo
FFP/Cryo is a combination blood product therapy that replaces clotting factors and fibrinogen to restore hemostatic function in patients with severe bleeding or coagulopathy.
FFP/Cryo is a combination blood product therapy that replaces clotting factors and fibrinogen to restore hemostatic function in patients with severe bleeding or coagulopathy. Used for Severe bleeding with coagulopathy, Massive transfusion protocol, Disseminated intravascular coagulation (DIC).
At a glance
| Generic name | FFP/Cryo |
|---|---|
| Also known as | Fresh Frozen Plasma, Cryoprecipitate |
| Sponsor | Biotest |
| Drug class | Blood product / Hemostatic agent |
| Modality | Biologic |
| Therapeutic area | Hematology / Critical Care |
| Phase | Phase 3 |
Mechanism of action
Fresh Frozen Plasma (FFP) contains multiple coagulation factors and fibrinogen, while Cryoprecipitate is enriched in fibrinogen, von Willebrand factor, and other cold-insoluble proteins. Together, they replenish depleted clotting factors and fibrinogen to correct coagulopathy and control bleeding in critical situations such as massive transfusion, disseminated intravascular coagulation, or severe liver disease.
Approved indications
- Severe bleeding with coagulopathy
- Massive transfusion protocol
- Disseminated intravascular coagulation (DIC)
- Fibrinogen deficiency or dysfunction
Common side effects
- Transfusion-related acute lung injury (TRALI)
- Allergic reaction
- Fluid overload
- Transfusion-transmitted infection (rare with modern screening)
Key clinical trials
- Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures (NA)
- Adjusted Fibrinogen Replacement Strategy (PHASE3)
- Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding. (NA)
- Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures. (NA)
- Platelet Transfusion During Neonatal Open Heart Surgery (PHASE4)
- Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial (NA)
- Plasma Transfusion in Major Vascular Surgery
- The Trauma- Formula-Driven Versus Lab-Guided Study (TRFL Study) (PHASE1, 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:
- FFP/Cryo CI brief — competitive landscape report
- FFP/Cryo updates RSS · CI watch RSS
- Biotest portfolio CI