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The EVARREST® Fibrin Sealant Patch Liver Study

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ClinicalTrials.gov Identifier: NCT01993888
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Description
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Brief Summary:
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Condition or disease Intervention/treatment Phase
Hemorrhage Biological: EVARREST® Fibrin Sealant Patch Other: Standard of Care (SoC) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: EVARREST® Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
 Biological: EVARREST® Fibrin Sealant Patch
Standard of Care (SoC)
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
 Other: Standard of Care (SoC)


Outcome Measures
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Primary Outcome Measures :
  1. Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization [ Time Frame: Intraoperative, 4 minutes following randomization ]
    Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.


Secondary Outcome Measures :
  1. Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization [ Time Frame: Intraoperative, 10 minutes following randomization ]
    Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.

  2. Absolute Time to Hemostasis [ Time Frame: Intraoperative, an average of 4.2 minutes following randomization ]
    The absolute time to achieve hemostasis at or after 4 minutes from randomization.

  3. Incidence of Re-bleeding Events From the TBS During the Study Follow-up [ Time Frame: Up to 60-days following surgery ]
  4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 60-days following surgery ]
  5. Incidence of Adverse Events That Were Potentially Related to Thrombotic Events [ Time Frame: Up to 60-days following surgery ]
    Number of participants with adverse events that were potentially related to thrombic events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
  • Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
  • Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria:

  • Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
  • TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST® to blood flow and pressure during healing and absorption of the product;
  • TBS with major arterial bleeding requiring suture or mechanical ligation;
  • Subjects admitted for trauma surgery;
  • Subject is a transplant patient for fulminant hepatic failure
  • Subject with TBS within an actively infected field;
  • Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
  • Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
  • Subjects who are known, current alcohol and / or drug abusers;
  • Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
  • Female subjects who are pregnant or nursing.
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): NCT01993888


Locations
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Sponsors and Collaborators
Ethicon, Inc.
Investigators
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Study Director: Richard Kocharian, MD Ethicon, Inc.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01993888    
Other Study ID Numbers: BIOS-13-005
2013-002535-24 ( EudraCT Number )
First Posted: November 25, 2013    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: April 2016
Keywords provided by Ethicon, Inc.:
Hepatobiliary Surgery
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants