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FS VH S/D 500 s-apr
FS VH S/D is a solvent/detergent-treated fresh frozen plasma product that provides multiple clotting factors and plasma proteins for hemostasis support.
FS VH S/D is a solvent/detergent-treated fresh frozen plasma product that provides multiple clotting factors and plasma proteins for hemostasis support. Used for Coagulopathy requiring clotting factor replacement, Massive transfusion / hemorrhage management, Deficiency of multiple clotting factors.
At a glance
| Generic name | FS VH S/D 500 s-apr |
|---|---|
| Also known as | Tisseel |
| Sponsor | Baxter Healthcare Corporation |
| Drug class | Blood product / Plasma derivative |
| Modality | Small molecule |
| Therapeutic area | Hematology / Transfusion Medicine |
| Phase | Phase 3 |
Mechanism of action
This is a pathogen-reduced fresh frozen plasma (FFP) prepared using solvent/detergent (S/D) treatment, which inactivates enveloped viruses while preserving coagulation factors and other plasma proteins. It is used as a hemostatic agent to replace deficient clotting factors in patients with coagulopathy or massive transfusion requirements. The S/D treatment process enhances viral safety compared to standard FFP.
Approved indications
- Coagulopathy requiring clotting factor replacement
- Massive transfusion / hemorrhage management
- Deficiency of multiple clotting factors
Common side effects
- Transfusion-related acute lung injury (TRALI)
- Allergic reaction
- Circulatory overload
- Infection transmission (reduced with S/D treatment)
Key clinical trials
- Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery (PHASE3)
- Fibrin Sealant for the Sealing of Dura Sutures (PHASE2)
- Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection (PHASE2)
- FS VH S/D 500 S-apr in Vascular Surgery (PHASE3)
- Fibrin Sealant Vascular Surgery Study (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:
- FS VH S/D 500 s-apr CI brief — competitive landscape report
- FS VH S/D 500 s-apr updates RSS · CI watch RSS
- Baxter Healthcare Corporation portfolio CI