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

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.

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.

Sponsors & Collaborators

• Artivion Inc.

  lead INDUSTRY

Principal Investigators

• Michael House, MD · Indiana University

• Marc Moon, MD · Washington University School of Medicine

• William Chapman, MD · Washington University School of Medicine

• Ronald P Kaufman, MD · Albany Medical College

• Edward Chen, MD · Emory University

• Robin Kim, MD · University of Utah

• Derek DuBay, MD · Medical University of South Carolina

• Adam Yopp, MD · University of Texas Southwestern Medical Center

• Michael Argenziano, MD · Columbia University

• K. Scott Coffield, MD · Baylor Scott and White Research Institute

• Sean Castellucci, DO · Manatee Medical Research Institute

• Viraj Master, MD · Emory University

• Kiran Turaga, MD · University of Chicago

• Carlo B Ramirez, MD · Thomas Jefferson University

• Keith B Allen, MD · St. Luke's Hospital

• Elaine Tseng, MD · San Francisco VA

• Michael Jessen, MD · University of Texas Southwestern Medical Center

• Michael D'Angelica, MD · Memorial Sloan Kettering Cancer Center

• Jonathan Silberstein, MD, MPH · Tulane University School of Medicine

• S.Chris Malaisrie, MD · Northwestern University

• Charles St. Hill, MD · University of Nevada, Las Vegas

• Douglas Scherr, MD · Weill Cornell Urology

• Thomas Guzzo, MD · University of Pennsylvania

• Aaron Milbank, MD · Minnesota Urology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2019-01-11

Completion

2019-02-20

Countries

• United States

Study Locations