Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System

NACompletedINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

January 11, 2019

Study Completion Date

February 20, 2019

Conditions
Blood Loss, Surgical
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

Unknown

Indiana University d/b/a/ Methodist Research Institute, Indianapolis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Artivion Inc.

INDUSTRY