HEMOBLAST Pivotal Clinical Investigation

Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries

The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.

Study Overview

• Status: Completed
• Conditions: Hemostasis
• Intervention / Treatment: Device: HEMOBLAST Bellows; Device: Absorbable gelatin sponge, USP with thrombin

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • CORE Institute
  • California
    • Los Angeles, California, United States
      • University of Southern California
    • Los Angeles, California, United States
      • University of California Los Angeles
    • Pasadena, California, United States
      • Lotus Clinical Research
  • Florida
    • Miami, Florida, United States
      • Miami Plastic Surgery
  • Hawaii
    • Honolulu, Hawaii, United States
      • Queens Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital - Johns Hopkins Medicine
  • Missouri
    • Saint Louis, Missouri, United States
      • Washington University in St. Louis
  • New Hampshire
    • Hanover, New Hampshire, United States
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States
      • Columbia University Medical Center / New York Presbyterian Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States
      • Duke University
    • Huntsville, North Carolina, United States
      • Hunstad Kortesis Center
  • Utah
    • Murray, Utah, United States
      • Intermountain Liver Disease and Transplant Center
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia
    • Danville, Virginia, United States
      • Spectrum Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;

  • Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
  • Subject undergoing cardiothoracic surgery is not allergic to protamine; and
  • Subject is 21 years of age or older.

Exclusion Criteria:

• • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;

  • Subject is undergoing a neurologic surgical procedure;
  • Subject is undergoing a spinal surgical procedure;
  • Subject is undergoing an emergency surgical procedure;
  • Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
  • Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery;
  • Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
  • Subject receiving antiplatelet medications within 5 days prior to surgery;
  • Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
  • Subject has an active or suspected infection at the surgical site;
  • Subject has had or has planned to receive any organ transplantation;
  • Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
  • Subject has ASA classification of 5;
  • Subject has a life expectancy of less than 3 months;
  • Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
  • Subject has a documented severe congenital or acquired immunodeficiency;
  • Subject has religious or other objections to porcine, bovine, or human components;
  • Subject in whom the investigational or control device will be used at the site of a valve replacement or repair;
  • Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant;
  • Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
  • Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.

Intraoperative Eligibility Criteria:

• Subject does not have an active or suspected infection at the surgical site;
• Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
• Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and
• Subject has a TBS with an SBSS score of 1, 2, or 3.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational; HEMOBLAST Bellows	Device: HEMOBLAST Bellows
ACTIVE_COMPARATOR: Control; Absorbable gelatin sponge, USP with thrombin	Device: Absorbable gelatin sponge, USP with thrombin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving Hemostasis	The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.	Intraoperative, 6 Minutes Post-Application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Preparation Time	The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.	Intraoperative
Proportion of Subjects Achieving Hemostasis	The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated	Intraoperative, 3 Minutes Post-Application

Collaborators and Investigators

• Sponsor: Biom'Up France SAS

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): March 27, 2017

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (ESTIMATE): May 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Thrombin; Gelatin Sponge, Absorbable
• Other Study ID Numbers: ETC 2015-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO