Progel Vascular Sealant

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959503
• Other study ID #: NEO13-100
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: April 6, 2017
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm of Ascending Aorta
• Aortic Aneurysm
• Aortic Valve Disorder
• Aortic Valve Stenosis
• Bicuspid Valve Disorder
• Disease

Intervention

Device:
• Progel Vascular Sealant

• Gelfoam Plus

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

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