Progel Vascular Sealant



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:November 2013
End Date:January 2016
Contact:Ryan Melloy
Phone:908-277-8094

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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

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.

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).

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.
We found this trial at
19
sites
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Chicago, IL
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Charlotte, North Carolina 28203
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Charlottesville, Virginia 22098
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Columbus, Ohio 43214
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Lincoln, Nebraska 68506
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Los Angeles, California 90048
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New York, New York 10021
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Plano, Texas 75093
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Pocatello, Idaho 83201
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Rochester, Minnesota 55905
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