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
1 other identifier
interventional
158
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 9, 2017
CompletedApril 10, 2017
April 1, 2017
1.1 years
October 8, 2013
June 27, 2016
April 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Progel Vascular Sealant
EXPERIMENTALProgel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus
ACTIVE COMPARATORGelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Interventions
Eligibility Criteria
You may qualify if:
- \. Subject must be ≥ 18 years of age.
- \. Subject is scheduled for elective, primary thoracic surgery involving the aortic valve, ascending aorta, or aortic arch on cardiopulmonary bypass.
- \. Subject has an expected life expectancy\> 6 months.
- \. Subject is willing and able to comply with all aspects of the study including follow-up schedule.
- \. Subject or authorized representative, has the ability to provide voluntary written informed consent.
- \. Subject is able to undergo an antegrade cardioplegia injection for evaluation of a leak at the aortic anastomotic site(s) during the procedure.
- \. Following this injection, subject has a leaking site where a topical sealant/hemostatic agent may be used to control bleeding.
You may not qualify if:
- \. Subject has Type A or other acute thoracic aortic dissection.
- \. Subject has undergone prior thoracic surgery (open thoracotomy not including interventional cardiology procedures).
- \. Subject is undergoing a planned concomitant procedure other than coronary artery bypass graft (CABG).
- \. Subject has a previous organ transplant.
- \. Subject has known or suspected preoperative coagulation disorder.
- \. Subject is allergic to human thrombin or has a history of allergic reactions after application of human thrombin.
- \. Subject is allergic to protamine.
- \. Subject has a Left Ventricular Assist Device (LVAD) or planned to receive an LVAD.
- \. Subject is undergoing emergency surgery.
- \. Subject is in chronic renal failure.
- \. Subject has a hematocrit \< 21% pre-operatively.
- \. Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
- \. Subject has a cardiac ejection fraction \<25%.
- \. Subject is scheduled for another cardiac surgery within 30 days of enrollment.
- \. Subject has an active or latent infection which is systemic or at the intended surgery site.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (19)
Cedars-Sinai
Los Angeles, California, 90048, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
Portneuf Hospital
Pocatello, Idaho, 83201, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Hospital
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Bryan Heart
Lincoln, Nebraska, 68510, United States
Cornell University
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Health Care System
Charlotte, North Carolina, 28203, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The Heart Hospital Baylor
Plano, Texas, 75093, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Health Sciences Center
Charlottesville, Virginia, 22904, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Related Publications (1)
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PMID: 38695613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dawn Heimer
- Organization
- C.R. Bard
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Khoynezhad, MD
Cedars-Sinai Heart Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 10, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 10, 2017
Results First Posted
January 9, 2017
Record last verified: 2017-04