NCT01639833

A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.

Conditions

• Cardiac Surgical Procedures
• Hemorrhage

Interventions

Type	Name	Description
DEVICE	Veriset Hemostatic Patch	Topical hemostat
DEVICE	TachoSil®	Topical Hemostat

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-07-13
• Last updated: 2014-07-03
• Results posted: 2014-07-03

Locations

12 sites across 3 countries: Belgium, Germany, Latvia