The Fibrin Pad CV Phase III Study

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Official Title
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A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Biological: EVARREST™ Fibrin Sealant Patch
* Biological: Topical hemostat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative Subjects must be willing to participate in the study and provide written informed consent. Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator; Exclusion Criteria: Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery. Female subjects who are pregnant or nursing. TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product; TBS with major arterial bleeding requiring suture or mechanical ligation; TBS involves an expanded polytetrafluoroethylene (ePTFE) graft TBS within an actively infected field; Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVARREST™ Fibrin Sealant Patch<br>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: EVARREST™ Fibrin Sealant Patch<br> <br> |
| Active Comparator: Topical hemostat<br>Equine collagen with Human Fibrinogen and Human Thrombin | Biological: Topical hemostat<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure | Intraoperative, 3 minutes following treatment application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | Intraoperative, 6 minutes following treatment application | 
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | Intraoperative, 10 minutes following treatment application | 
| Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS | Intra-operative, prior initiation of final chest wall closure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Fibrin Sealant, Hemostatics, Coagulants