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The Fibrin Pad Liver Study

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fibrin Pad
Standard of Care
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Hemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 must be willing to participate in the study, and provide written informed consent

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 the FP 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 drug or device research study within 30 days of surgery
  • Female subjects who are pregnant or nursing

Sites / Locations

  • Flinders Medical Centre
  • Queen Elizabeth Hospital
  • The Alfred
  • University Hospital of the University of Saarland
  • University Medical Center
  • Auckland City Hospital
  • Queen Elizabeth Hospital
  • Addenbrookes Hospital
  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Fibrin Pad

Standard of Care

Arm Description

Biologic

Procedure

Outcomes

Primary Outcome Measures

Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).

Secondary Outcome Measures

Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Absolute time to hemostasis
Subjects requiring re-treatment
Incidence of adverse events potentially related to re-bleeding at TBS
Incidence of adverse events potentially related to thrombotic events
Incidence of adverse events

Full Information

First Posted
July 6, 2010
Last Updated
January 17, 2014
Sponsor
Ethicon, Inc.
Collaborators
OMRIX Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01166243
Brief Title
The Fibrin Pad Liver Study
Official Title
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
Collaborators
OMRIX Biopharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin Pad
Arm Type
Experimental
Arm Description
Biologic
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Procedure
Intervention Type
Biological
Intervention Name(s)
Fibrin Pad
Intervention Description
Fibrin Pad 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).
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
Primary Outcome Measure Information:
Title
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Time Frame
Intra-operative
Title
Absolute time to hemostasis
Time Frame
Intraoperative
Title
Subjects requiring re-treatment
Time Frame
Intraoperative
Title
Incidence of adverse events potentially related to re-bleeding at TBS
Time Frame
Intraoperative through 60 days
Title
Incidence of adverse events potentially related to thrombotic events
Time Frame
Intraoperative through 60 days
Title
Incidence of adverse events
Time Frame
Intraoperative through 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 must be willing to participate in the study, and provide written informed consent 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 the FP 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 drug or device research study within 30 days of surgery Female subjects who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Hammond, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3044
Country
Australia
Facility Name
University Hospital of the University of Saarland
City
Strasse
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
University Medical Center
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23216780
Citation
Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.
Results Reference
result
PubMed Identifier
26636489
Citation
Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.
Results Reference
derived

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The Fibrin Pad Liver Study

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