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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
Cedars-Sinai
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
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
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