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

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: 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

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE May 24, 2016
Results First Submitted Date  ICMJE October 8, 2018
Results First Posted Date  ICMJE November 7, 2018
Last Update Posted Date December 27, 2018
Actual Study Start Date  ICMJE July 18, 2016
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
The Primary Efficacy Endpoint of This Clinical Investigation is Non-inferiority of HEMOBLAST™ Relative to G+T for Success at Achieving Hemostasis Within 6 Minutes. [ Time Frame: Intraoperative ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
  • • Superiority of HEMOBLAST™ Relative to G+T in Mean Preparation Time From the Opening of Package to Product Being Ready to Use [ Time Frame: Intraoperative ]
  • • Non-inferiority of HEMOBLAST™ Relative to G+T for Success at Achieving Hemostasis Within 3 Minutes [ Time Frame: Intraoperative ]
  • • Superiority of HEMOBLAST™ Relative to G+T for Success at Achieving Hemostasis Within 6 Minutes [ Time Frame: Intraoperative ]
  • • Superiority of HEMOBLAST™ Relative to G+T for Success at Achieving Hemostasis Within 3 Minutes [ Time Frame: Intraoperative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HEMOBLAST Pivotal Clinical Investigation
Official Title  ICMJE Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hemostasis
Intervention  ICMJE
  • Device: HEMOBLAST Bellows
  • Device: Absorbable gelatin sponge, USP with thrombin
Study Arms  ICMJE
  • Experimental: Investigational
    HEMOBLAST Bellows
    Intervention: Device: HEMOBLAST Bellows
  • Active Comparator: Control
    Absorbable gelatin sponge, USP with thrombin
    Intervention: Device: Absorbable gelatin sponge, USP with thrombin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2018)
258
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2016)
450
Actual Study Completion Date  ICMJE March 27, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02780869
Other Study ID Numbers  ICMJE ETC 2015-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biom'Up France SAS
Study Sponsor  ICMJE Biom'Up France SAS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Chapman, MD Washington University School of Medicine
PRS Account Biom'Up France SAS
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP