The Fibrin Pad Cardiovascular Study

Study Overview
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Brief Summary
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This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Official Title
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A Randomized, Controlled, Comparative Phase II 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™
* Biological: Topical hemostat
* Other: Standard of Care


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 must be willing to participate in the study and provide written informed consent. 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 30 day follow up period after surgery. Female subjects who are pregnant or nursing.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVARREST™<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™<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).<br>|
| Active Comparator: Topical hemostat<br>Equine collagen with Human Fibrinogen and Human Thrombin | Biological: Topical hemostat<br>* Equine collagen with Human Fibrinogen and Human Thrombin<br>|
| Active Comparator: Standard of Care<br>SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | Other: Standard of Care<br>* SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 closur | Intraoperative, 3 minutes following treatment application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative, 6 minutes following treatment application | 
| Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | Number of subjects achieving hemostatic success at 10 minutes following treatment application. | Intraoperative, 10 minutes following treatment application | 
| 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 re-bleeding requiring treatment | Intra-operative, prior initiation of final chest wall closure. Safety Issue: | 
| Number of Participants With Adverse Events Potentially Related to Thrombotic Events | The number of subjects with an adverse event potentially related to a thrombotic event | 30 days (+ 14 days) following surgery |