HEMOBLAST Pilot Clinical Investigation

Completed · Phase 1

Conditions studied: Hemostasis

In brief

The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.

Key facts

Study ID: NCT02502019
Run by: Biom'Up France SAS
People needed: 27
Starts: 2015-08-01
Expected to finish: 2016-03-01
Last updated by the study team: 2019-02-15

Who can join

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

You may qualify if…

• Subject is undergoing an elective open 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;
Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and
Subject is 21 years of age or older.
Subject does not have an active or suspected infection at the surgical site;
Subject in whom the Investigator is able to identify a target bleeding site (TBS) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and
Subject has a TBS with an SBSS score of 1, 2, or 3.

You may not qualify if…

• Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
Subject is undergoing a spinal surgical procedure;
Subject is undergoing a neurologic 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 and/or International Normalized Ratio > 1.5 within 4 weeks of surgery;
Subject had chronic corticosteroid use within 2 weeks prior to surgery;
Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery;
Subject has an active or suspected infection at the surgical site;
Subject has had or has planned 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 > 4;
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 or bovine components;
Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint 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.

Where it is running

University of Southern California — Los Angeles, California, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Danville Orthopedic Clinic — Danville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.