NCT01681030

The Fibrin Pad Cardiovascular Study

A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BIOLOGICAL	EVARREST™	EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
BIOLOGICAL	Topical hemostat	Equine collagen with Human Fibrinogen and Human Thrombin
OTHER	Standard of Care	SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-09-03
• First posted: 2012-09-07
• Last updated: 2018-06-12
• Results posted: 2018-03-07

Locations

6 sites across 1 country: United States