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CompletedNCT01166243Updated Jan 20, 2014

The Fibrin Pad Liver Study

A Phase 3 interventional study of Fibrin Pad and Standard of Care in Hemorrhage, sponsored by Ethicon, Inc.. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-20.

Sponsored by Ethicon, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Hemorrhage

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Keywords

  • Hemostasis
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 84 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Fibrin Pad

    Biologic

    Biological: Fibrin Pad

  • Other
    Standard of Care

    Procedure

    Procedure: Standard of Care

Interventions

  • BiologicalFibrin Pad

    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).

  • ProcedureStandard of Care

    Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

06

What researchers measure

Primary outcomes

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

    Time frame: Intra-operative

Secondary outcomes

  1. Proportion of subjects achieving hemostasis success at 10-minutes following randomization.

    Time frame: Intra-operative

  2. Absolute time to hemostasis

    Time frame: Intraoperative

  3. Subjects requiring re-treatment

    Time frame: Intraoperative

  4. Incidence of adverse events potentially related to re-bleeding at TBS

    Time frame: Intraoperative through 60 days

  5. Incidence of adverse events potentially related to thrombotic events

    Time frame: Intraoperative through 60 days

  6. Incidence of adverse events

    Time frame: Intraoperative through 60 days

07

Study locations

9 sites
  • Flinders Medical Centre
    Bedford Park, South Australia 5042, Australia
  • Queen Elizabeth Hospital
    Woodville, South Australia 5011, Australia
  • The Alfred
    Melbourne, Victoria 3044, Australia
  • University Hospital of the University of Saarland
    Strasse, D-66421, Germany
  • University Medical Center
    Groningen, 9713, Netherlands
  • Auckland City Hospital
    Grafton, 1010, New Zealand
  • Queen Elizabeth Hospital
    Birmingham, B15 2TH, United Kingdom
  • Addenbrookes Hospital
    Cambridge, CB2 0QQ, United Kingdom
  • Royal Infirmary of Edinburgh
    Edinburgh, EH16 4SA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 23216780 ↗
  • 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. PubMed 26636489 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01166243
Lead sponsor
Ethicon, Inc.
Collaborators
OMRIX Biopharmaceuticals
Responsible party
Sponsor
First posted
Jul 21, 2010
Start date
Jul 2010
Primary completion
Aug 2011
Completion
Oct 2011
Last update
Jan 20, 2014

Study contacts

Jeff Hammond, MD
study director · Ethicon, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Ethicon, Inc.

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