Progel Vascular Sealant

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Disorder; Aneurysm of Ascending Aorta; Bicuspid Valve Disorder
• Intervention / Treatment: Device: Progel Vascular Sealant; Device: Gelfoam Plus

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).

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Idaho
    • Pocatello, Idaho, United States, 83201
      • Portneuf Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Hospital
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Bryan Heart
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10021
      • Cornell University
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Health Care System
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia Health Sciences Center
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progel Vascular Sealant; Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.	Device: Progel Vascular Sealant; Other Names: Progel
ACTIVE_COMPARATOR: Gelfoam Plus; Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.	Device: Gelfoam Plus; Other Names: Gelfoam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.	5 minutes after application
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
Chest Tube Drainage Volume Following Surgery.	24 hours post procedure
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery	24 hours post procedure
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.	Intra-procedurally
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.	30 days post procedure
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days	30 days post procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Ali Khoynezhad, MD, Cedars-Sinai Heart Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (ESTIMATE): October 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: CABG; Reconstruction; Aorta; Aortic; Bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Disease; Aortic Valve Stenosis; Aneurysm; Aortic Valve Disease; Hemostatics; Coagulants; Gelatin Sponge, Absorbable
• Other Study ID Numbers: NEO13-100