Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
258 participants
INTERVENTIONAL
2016-07-18
2017-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Investigational
HEMOBLAST Bellows
HEMOBLAST Bellows
Control
Absorbable gelatin sponge, USP with thrombin
Absorbable gelatin sponge, USP with thrombin
Interventions
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HEMOBLAST Bellows
Absorbable gelatin sponge, USP with thrombin
Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
ALL
No
Sponsors
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Biom'Up France SAS
INDUSTRY
Responsible Party
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Principal Investigators
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William Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ETC 2015-002
Identifier Type: -
Identifier Source: org_study_id