The Fibrin Pad CV Phase III Study

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
Enrollment: 156
Study Start Date: January 2014
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: EVARREST™ Fibrin Sealant Patch
- Active Comparator: Topical hemostat