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Progel Vascular Sealant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959503
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : January 9, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Aneurysm of Ascending Aorta Aortic Valve Disorder Bicuspid Valve Disorder Device: Progel Vascular Sealant Device: Gelfoam Plus Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: Progel

Active Comparator: Gelfoam Plus
Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Device: Gelfoam Plus
Other Name: Gelfoam




Primary Outcome Measures :
  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. [ Time Frame: 0 seconds to 600 seconds ]

Secondary Outcome Measures :
  1. Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. [ Time Frame: 5 minutes after application ]
  2. Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. [ Time Frame: 0 seconds to 10 minutes ]
  3. Chest Tube Drainage Volume Following Surgery. [ Time Frame: 24 hours post procedure ]
  4. Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery [ Time Frame: 24 hours post procedure ]
  5. Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. [ Time Frame: Intra-procedurally ]
  6. Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. [ Time Frame: 30 days post procedure ]
  7. Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days [ Time Frame: 30 days post procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959503


Locations
Show Show 19 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Ali Khoynezhad, MD Cedars-Sinai Heart Institute
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01959503    
Other Study ID Numbers: NEO13-100
First Posted: October 10, 2013    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by C. R. Bard:
Aorta
Aortic
Reconstruction
CABG
Bypass
Additional relevant MeSH terms:
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Aneurysm
Aortic Valve Stenosis
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Gelatin Sponge, Absorbable
Hemostatics
Coagulants