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Trial record 1 of 1 for:    NCT02780869
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HEMOBLAST Pivotal Clinical Investigation

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ClinicalTrials.gov Identifier: NCT02780869
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : November 7, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Biom'Up France SAS

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemostasis Device: HEMOBLAST Bellows Device: Absorbable gelatin sponge, USP with thrombin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : March 27, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational
HEMOBLAST Bellows
 Device: HEMOBLAST Bellows
Active Comparator: Control
Absorbable gelatin sponge, USP with thrombin
 Device: Absorbable gelatin sponge, USP with thrombin


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects Achieving Hemostasis [ Time Frame: Intraoperative, 6 Minutes Post-Application ]
    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.


Secondary Outcome Measures :
  1. Product Preparation Time [ Time Frame: Intraoperative ]
    The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.

  2. Proportion of Subjects Achieving Hemostasis [ Time Frame: Intraoperative, 3 Minutes Post-Application ]
    The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT02780869


Locations
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Sponsors and Collaborators
Biom'Up France SAS
Investigators
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Principal Investigator: William Chapman, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Biom'Up France SAS:
Study Protocol  [PDF] June 20, 2016
Statistical Analysis Plan  [PDF] July 1, 2016

More Information
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Responsible Party: Biom'Up France SAS
ClinicalTrials.gov Identifier: NCT02780869    
Other Study ID Numbers: ETC 2015-002
First Posted: May 24, 2016    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants