324
Participants
Start Date
April 30, 2015
Primary Completion Date
January 11, 2019
Study Completion Date
February 20, 2019
PerClot Polysaccharide Hemostatic System
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of PerClot. The prescribed hemostatic agent will be applied according to its Instructions for Use.
Arista AH
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of the control device. The prescribed hemostatic agent will be applied according to its Instructions for Use.
Indiana University d/b/a/ Methodist Research Institute, Indianapolis
Lead Sponsor
Artivion Inc.
INDUSTRY