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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Cardiac Surgical Procedures Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Veriset Hemostatic Patch

Topical Hemostat

Group Type EXPERIMENTAL

Veriset Hemostatic Patch

Intervention Type DEVICE

Topical hemostat

TachoSil®

Topical Hemostat

Group Type ACTIVE_COMPARATOR

TachoSil®

Intervention Type DEVICE

Topical Hemostat

Interventions

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Veriset Hemostatic Patch

Topical hemostat

Intervention Type DEVICE

TachoSil®

Topical Hemostat

Intervention Type DEVICE

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.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No