Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

Study Overview

• Status: Completed
• Conditions: Cardiothoracic Surgery
• Intervention / Treatment: Device: HEMOBLAST Bellows; Device: FLOSEAL

Detailed Description

A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States.

The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Moanalua Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • Ochsner Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Preoperative Inclusion Criteria

• Subject is undergoing a non-emergent cardiothoracic surgery; and
• Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation.

Preoperative Exclusion Criteria

• 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 religious or other objections to porcine or bovine components; and
• Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator.

Intraoperative Inclusion Criteria

• 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 hemostasis are ineffective or impractical; and
• Subject has a TBS with minimal, mild, or moderate bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HEMOBLAST Bellows (Hemostatic Device); Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use	Device: HEMOBLAST Bellows; The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
ACTIVE_COMPARATOR: FLOSEAL (Hemostatic Device); Bleeding sites will be treated with FLOSEAL per its approved Indications for Use	Device: FLOSEAL; The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes	The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes	The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.	Intraoperative

Collaborators and Investigators

• Sponsor: Biom'Up France SAS
• Investigators: Principal Investigator: Brian Bruckner, MD, The Methodist Hospital Research Institute

Publications and helpful links

General Publications

• Dang NC, Ardehali A, Bruckner BA, Parrino PE, Gillen DL, Hoffman RW, Spotnitz R, Cavoores S, Shorn IJ, Manson RJ, Spotnitz WD. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2020 Feb;35(2):313-319. doi: 10.1111/jocs.14376. Epub 2019 Nov 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): June 28, 2019
• Study Completion (ACTUAL): June 28, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (ACTUAL): October 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ETC 2018-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No