drugset / Trial / NCT02040428
The Fibrin Pad CV Phase III Study
RandomizedParallel-groupSingle-blindTreatment
Summary
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
Timeline
- Start
- 2014-01-01
- Primary completion
- 2015-07-01
- Completion
- 2015-09-01
Outcome
Met primary endpoint
registry NUMBER EVARREST Fibrin Sealant Patch: 57 Participants NUMBER TachoSil: 36 Participants analysis (superiority or other test); EVARREST Fibrin Sealant Patch vs TachoSil; p = 0.0001 NCT02040428 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EVARREST™ Fibrin Sealant Patch | Protein / enzyme biologic | — | — |
| Comparator | Equine collagen | Protein / enzyme biologic | — | — |
| Comparator | Fibrinogen Concentrate Human | Protein / enzyme biologic | — | — |
| Comparator | Human Thrombin | Protein / enzyme biologic | — | — |