HEMOBLAST Pivotal Clinical Investigation

Completed · Not applicable

Conditions studied: Hemostasis

In brief

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.

Key facts

Study ID: NCT02780869
Run by: Biom'Up France SAS
People needed: 258
Starts: 2016-07-18
Expected to finish: 2017-03-27
Last updated by the study team: 2018-12-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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;
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

Where it is running

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

Full record on ClinicalTrials.gov

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