HEMOBLAST Pivotal Clinical Investigation

NCT02780869 | Completed Results DMC

• 1 other identifier: ETC 2015-002
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Product Preparation Time

  Intraoperative

• Proportion of Subjects Achieving Hemostasis

  Intraoperative, 3 Minutes Post-Application

Study Arms (2)

Investigational

EXPERIMENTAL

HEMOBLAST Bellows

Device: HEMOBLAST Bellows

Control

ACTIVE COMPARATOR

Absorbable gelatin sponge, USP with thrombin

Device: Absorbable gelatin sponge, USP with thrombin

Interventions

HEMOBLAST Bellows DEVICE

Investigational

Absorbable gelatin sponge, USP with thrombin DEVICE

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Sites (17)

CORE Institute

Phoenix, Arizona, United States

Location

University of California Los Angeles

Los Angeles, California, United States

Location

University of Southern California

Los Angeles, California, United States

Location

Lotus Clinical Research

Pasadena, California, United States

Location

Miami Plastic Surgery

Miami, Florida, United States

Location

Queens Medical Center

Honolulu, Hawaii, United States

Location

Suburban Hospital - Johns Hopkins Medicine

Bethesda, Maryland, 20814, United States

Location

Washington University in St. Louis

St Louis, Missouri, United States

Location

Dartmouth Hitchcock Medical Center

Hanover, New Hampshire, United States

Location

Columbia University Medical Center / New York Presbyterian Hospital

New York, New York, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Location

Duke University

Durham, North Carolina, United States

Location

Hunstad Kortesis Center

Huntsville, North Carolina, United States

Location

Intermountain Liver Disease and Transplant Center

Murray, Utah, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

Spectrum Medical

Danville, Virginia, United States

Location

MeSH Terms

Interventions

Gelatin Sponge, Absorbable

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Rachel Hoffman, Vice President Clinical Operations North America
• Organization: Biom'up

r.hoffman@biomup.com

404-702-9253

Study Officials

• William Chapman, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 24, 2016
• Study Start: July 18, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 27, 2017
• Last Updated: December 27, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)