HEMOBLAST Pivotal Clinical Investigation

Hemostasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780869
• Other study ID #: ETC 2015-002
• Status: Completed
• Phase: N/A
• Start date: July 18, 2016
• Est. completion date: March 27, 2017

Study information

• Verified date: December 2018
• Source: Biom'Up SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: March 27, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• HEMOBLAST Bellows

• Absorbable gelatin sponge, USP with thrombin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biom'Up SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Product Preparation Time	The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.	Intraoperative
Secondary	Proportion of Subjects Achieving Hemostasis	The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated	Intraoperative, 3 Minutes Post-Application