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Fibrin Sealant Grifols
Fibrin Sealant Grifols is a topical hemostatic agent that forms a fibrin clot to seal wounds and control bleeding during surgical procedures.
Fibrin Sealant Grifols is a topical hemostatic agent that forms a fibrin clot to seal wounds and control bleeding during surgical procedures. Used for Hemostasis and tissue sealing during surgical procedures, Reduction of postoperative bleeding in general, cardiac, and vascular surgery.
At a glance
| Generic name | Fibrin Sealant Grifols |
|---|---|
| Also known as | FS Grifols |
| Sponsor | Instituto Grifols, S.A. |
| Drug class | Fibrin sealant / Hemostatic agent |
| Target | Fibrinogen (substrate for thrombin-catalyzed polymerization) |
| Modality | Biologic |
| Therapeutic area | Surgery / Hemostasis |
| Phase | Phase 3 |
Mechanism of action
The product combines human fibrinogen and human thrombin to create a two-component system that, when mixed at the surgical site, polymerizes fibrinogen into fibrin strands, forming a stable clot. This mechanical seal provides hemostasis and can also serve as a tissue adhesive to promote wound healing and reduce postoperative bleeding complications.
Approved indications
- Hemostasis and tissue sealing during surgical procedures
- Reduction of postoperative bleeding in general, cardiac, and vascular surgery
Common side effects
- Allergic reaction
- Thromboembolism (rare, with systemic absorption)
- Infection at surgical site
- Hematoma formation
Key clinical trials
- A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants (PHASE3)
- Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery (PHASE3)
- Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries (PHASE3)
- Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries (PHASE3)
- Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis (PHASE2, PHASE3)
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:
- Fibrin Sealant Grifols CI brief — competitive landscape report
- Fibrin Sealant Grifols updates RSS · CI watch RSS
- Instituto Grifols, S.A. portfolio CI