Clinical trial NCT01959503: Progel Vascular Sealant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Aneurysm of Ascending Aorta
Aortic Valve Disorder
Bicuspid Valve Disorder
Keywords: Aorta
Aortic
Reconstruction
CABG
Bypass
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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.

Primary outcomes:
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.
timeFrame: 0 seconds to 600 seconds
Secondary outcomes:
measure: Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
timeFrame: 5 minutes after application
measure: Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
timeFrame: 0 seconds to 10 minutes
measure: Chest Tube Drainage Volume Following Surgery.
timeFrame: 24 hours post procedure
measure: Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
timeFrame: 24 hours post procedure
measure: Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
timeFrame: Intra-procedurally
measure: Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
timeFrame: 30 days post procedure
measure: Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Pocatello
country: United States
facility: Portneuf Hospital
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Charlotte
country: United States
facility: Carolinas Health Care System
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health Sciences Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Cedars-Sinai Heart Institute
name: Ali Khoynezhad, MD
role: PRINCIPAL_INVESTIGATOR
References: