Brief Summary
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.
Brief Title
Progel Vascular Sealant
Detailed Description
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Aortic Valve Stenosis
Aneurysm of Ascending Aorta
Aortic Valve Disorder
Bicuspid Valve Disorder
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Aorta
Aortic
Reconstruction
CABG
Bypass
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01959503
Org Class
Industry
Org Full Name
C. R. Bard
Org Study Id
NEO13-100
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Measure
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.
Outcome Time Frame
0 seconds to 600 seconds
Secondary Outcomes
Outcome Time Frame
5 minutes after application
Outcome Measure
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Outcome Time Frame
0 seconds to 10 minutes
Outcome Measure
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Outcome Time Frame
24 hours post procedure
Outcome Measure
Chest Tube Drainage Volume Following Surgery.
Outcome Time Frame
24 hours post procedure
Outcome Measure
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Outcome Time Frame
Intra-procedurally
Outcome Measure
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Outcome Time Frame
30 days post procedure
Outcome Measure
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Outcome Time Frame
30 days post procedure
Outcome Measure
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Michler
Investigator Email
RMICHLER@MONTEFIORE.ORG
Investigator Phone
rmichler