Progel Vascular Sealant

Study Overview
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Brief Summary
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This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Detailed Description
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The primary objective of this clinical study is to compare the time to hemostasis at the aortic anastomotic suture line in subjects receiving Progel (Test group) to that in subjects receiving Gelfoam Plus (Control group) on anastomotic suture lines involving the aortic valve, ascending aorta, or aortic arch while on cardiopulmonary bypass. The primary endpoint of this study is the time to achieve hemostasis at the aortic anastomotic suture line from the time surgical clamps are released to cessation of leakage at the treated anastomotic site with either Progel (Test) or Gelfoam Plus (Control).

Official Title
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A Prospective, Randomized Study to Compare Progel Vascular Sealant to Gelfoam Plus as an Adjunct for the Control of Bleeding in Subjects Undergoing Thoracic Aortic Surgery

Conditions
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Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder

Intervention / Treatment
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* Device: Progel Vascular Sealant
* Device: Gelfoam Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subject must be ≥ 18 years of age. 2. Subject is scheduled for elective, primary thoracic surgery involving the aortic valve, ascending aorta, or aortic arch on cardiopulmonary bypass. 3. Subject has an expected life expectancy> 6 months. 4. Subject is willing and able to comply with all aspects of the study including follow-up schedule. 5. Subject or authorized representative, has the ability to provide voluntary written informed consent. Intra-operative Inclusion Criteria: 1. Subject is able to undergo an antegrade cardioplegia injection for evaluation of a leak at the aortic anastomotic site(s) during the procedure. 2. Following this injection, subject has a leaking site where a topical sealant/hemostatic agent may be used to control bleeding. Exclusion Criteria: 1. Subject has Type A or other acute thoracic aortic dissection. 2. Subject has undergone prior thoracic surgery (open thoracotomy not including interventional cardiology procedures). 3. Subject is undergoing a planned concomitant procedure other than coronary artery bypass graft (CABG). 4. Subject has a previous organ transplant. 5. Subject has known or suspected preoperative coagulation disorder. 6. Subject is allergic to human thrombin or has a history of allergic reactions after application of human thrombin. 7. Subject is allergic to protamine. 8. Subject has a Left Ventricular Assist Device (LVAD) or planned to receive an LVAD. 9. Subject is undergoing emergency surgery. 10. Subject is in chronic renal failure. 11. Subject has a hematocrit < 21% pre-operatively. 12. Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis. 13. Subject has a cardiac ejection fraction <25%. 14. Subject is scheduled for another cardiac surgery within 30 days of enrollment. 15. Subject has an active or latent infection which is systemic or at the intended surgery site. 16. Subject is immuno-compromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders. 17. Subject is pregnant by a positive pregnancy test or has plans to become pregnant during the study period or is currently breast-feeding. 18. Subject is unwilling to receive blood products. 19. Subject has participated in another investigational research study within 30 days of enrollment. 20. In the opinion of the investigator, the subject has a clinical condition that would preclude the use of the study device, preclude the subject from completing the follow-up requirements, or would complicate the evaluation of this study.

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: Progel Vascular Sealant<br>Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. | Device: Progel Vascular Sealant<br> <br> * Other names: Progel;|
| Active Comparator: Gelfoam Plus<br>Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. | Device: Gelfoam Plus<br> <br> * Other names: Gelfoam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam. |  | 0 seconds to 600 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. |  | 5 minutes after application | 
| Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. |  | 0 seconds to 10 minutes | 
| Chest Tube Drainage Volume Following Surgery. |  | 24 hours post procedure | 
| Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery |  | 24 hours post procedure | 
| Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. |  | Intra-procedurally | 
| Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. |  | 30 days post procedure | 
| Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days |  | 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Aortic, Reconstruction, CABG, Bypass