Progel Vascular Sealant
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|ClinicalTrials.gov Identifier: NCT01959503|
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : January 9, 2017
Last Update Posted : April 10, 2017
|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|
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 (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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 ]
- Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. [ Time Frame: 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. [ Time Frame: 0 seconds to 10 minutes ]
- Chest Tube Drainage Volume Following Surgery. [ Time Frame: 24 hours post procedure ]
- Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery [ Time Frame: 24 hours post procedure ]
- Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. [ Time Frame: Intra-procedurally ]
- Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. [ Time Frame: 30 days post procedure ]
- Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days [ Time Frame: 30 days post procedure ]
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
|Principal Investigator:||Ali Khoynezhad, MD||Cedars-Sinai Heart Institute|