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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiac Surgical Procedures, Hemorrhage

Intervention / Treatment
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* Device: Veriset Hemostatic Patch
* Device: TachoSil®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent. Subject is ≥18 years of age. Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death. Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin. Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding. Subject has an estimated life expectancy of less than 6 months. Subject is unwilling to receive blood products. Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment. The subject has participated in another investigational drug or device research study within 30 days of enrollment. Exclusion Criteria: Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent. TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate). It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes. Incidental finding of any other pre-operative exclusion criteria Subject does not have an appropriate TBS. TBS Bleeding Assessment is Type 1 (No bleeding) or 4 (Severe/Surgical/Life Threatening). Subject has an active local infection at the surgical site. Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veriset Hemostatic Patch<br>Topical Hemostat | Device: Veriset Hemostatic Patch<br>* Topical hemostat<br>|
| Active Comparator: TachoSil®<br>Topical Hemostat | Device: TachoSil®<br>* Topical Hemostat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis (TTH) | Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis at All Treated Bleeding Sites Within 3 Minutes | The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application. | Day 0 |