Aortic Valve Stenosis Clinical Trial
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
Verified date | April 2017 |
Source | C. R. Bard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 158 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado | Aurora | Colorado |
United States | Montefiore Medical Center | Bronx | New York |
United States | Carolinas Health Care System | Charlotte | North Carolina |
United States | University of Virginia Health Sciences Center | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | University of Florida | Gainesville | Florida |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Bryan Heart | Lincoln | Nebraska |
United States | Cedars-Sinai | Los Angeles | California |
United States | Intermountain Medical Center | Murray | Utah |
United States | Cornell University | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | The Heart Hospital Baylor | Plano | Texas |
United States | Portneuf Hospital | Pocatello | Idaho |
United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
United States | Mayo Clinic Hospital | Rochester | Minnesota |
United States | Washington University | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 5 minutes after application | ||
Secondary | 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 | ||
Secondary | Chest Tube Drainage Volume Following Surgery. | 24 hours post procedure | ||
Secondary | Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery | 24 hours post procedure | ||
Secondary | Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. | Intra-procedurally | ||
Secondary | Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. | 30 days post procedure | ||
Secondary | Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days | 30 days post procedure |
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