Clinical trial NCT02780869: HEMOBLAST Pivotal Clinical Investigation
Official title: Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2016-05-24
Enrollment: 258
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Subjects Achieving Hemostasis
timeFrame: Intraoperative, 6 Minutes Post-Application
Secondary outcomes:
measure: Product Preparation Time
timeFrame: Intraoperative
measure: Proportion of Subjects Achieving Hemostasis
timeFrame: Intraoperative, 3 Minutes Post-Application
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CORE Institute
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Miami
country: United States
facility: Miami Plastic Surgery
state: Florida
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Bethesda
country: United States
facility: Suburban Hospital - Johns Hopkins Medicine
state: Maryland
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Hanover
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University Medical Center / New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Huntsville
country: United States
facility: Hunstad Kortesis Center
state: North Carolina
city: Murray
country: United States
facility: Intermountain Liver Disease and Transplant Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Danville
country: United States
facility: Spectrum Medical
state: Virginia
Study officials:
affiliation: Washington University School of Medicine
name: William Chapman, MD
role: PRINCIPAL_INVESTIGATOR
References: