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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725098
Recruitment Status : Completed
First Posted : October 30, 2018
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Biom'Up France SAS

Study Description
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Brief Summary:
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

Condition or disease Intervention/treatment Phase
Cardiothoracic Surgery Device: HEMOBLAST Bellows Device: FLOSEAL Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes [ Time Frame: Intraoperative ]
    The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.


Secondary Outcome Measures :
  1. 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes [ Time Frame: Intraoperative ]
    The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725098


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Hawaii
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70124
United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biom'Up France SAS
Investigators
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Principal Investigator: Brian Bruckner, MD Houston Methodist
  Study Documents (Full-Text)

Documents provided by Biom'Up France SAS:
Study Protocol and Statistical Analysis Plan  [PDF] October 15, 2018

More Information
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Publications:

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Responsible Party: Biom'Up France SAS
ClinicalTrials.gov Identifier: NCT03725098    
Other Study ID Numbers: ETC 2018-005
First Posted: October 30, 2018    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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