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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.

Three hundred and twenty four subjects across a maximum of 25 investigational sites undergoing open elective cardiac, general, or urological surgical procedures who meet the eligibility criteria will be intraoperatively randomized to receive no more than the entire contents of up to two 5 gram bellows of either the investigational device or a control hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm² and whose anatomic application site is smaller than or equal to 47cm², when bleeding is within the pre-defined bleeding severity range after any applicable conventional means for hemostasis are attempted as specified in the intraoperative procedures.

Each investigational site is expected to enroll approximately 13-40 subjects. All investigational sites will be located in the U.S. Follow-up will occur at hospital discharge and 6 weeks post-device application. For oncologic subjects, an additional follow up will occur at 24 months post device application.


Detailed Summary:
Sponsor: CryoLife, Inc.

Current Primary Outcome: Achievement of hemostasis [ Time Frame: 7 minutes following application ]

The primary objective of this clinical investigation is to demonstrate non-inferiority in the achievement of hemostasis of the treated bleeding site at 7 minutes in subjects receiving PerClot compared to those receiving a control hemostatic device. The primary endpoint is the proportion of subjects achieving hemostasis of the treated lesion at 7 minutes in each treatment group.


Original Primary Outcome: Achievement of hemostasis [ Time Frame: 7 minutes following application ]

Hemostasis is defined as complete cessation of bleeding. If the surgeon visually observes complete cessation of bleeding, this will be considered successful hemostasis; If the surgeon visually observes bleeding egressing from the randomized study device, this will be considered a failure of hemostasis.


Current Secondary Outcome: Achievement of hemostasis [ Time Frame: 5 minutes following application ]

The secondary objective of this investigation is to compare the achievement of hemostasis of the treated bleeding site at 5 minutes for subjects receiving PerClot compared to those receiving a control hemostatic device. The secondary endpoint is the proportion of subjects achieving hemostasis of the treated bleeding site at 5 minutes in each treatment group.


Original Secondary Outcome:

Information By: CryoLife, Inc.

Dates:
Date Received: February 3, 2015
Date Started: April 2015
Date Completion: May 2018
Last Updated: March 24, 2017
Last Verified: March 2017