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 |
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.
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).
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
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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