At a glance
ClinicalIndex Comparison RecordN/ACompleted· 90 enrolled
Drug / intervention
Veriset Hemostatic Patch +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Veriset Hemostatic Patch and TachoSil® for Cardiac Surgical Procedures and Hemorrhage. Completed, enrolled 90 participants across 12 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgical Procedures, Hemorrhage
CountriesBelgium, Germany, Latvia
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartAug 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedJul 13, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.0 years ago
Interventions
Veriset Hemostatic Patchdevice
Topical hemostat
TachoSil®device
Topical Hemostat