The Fibrin Pad Liver Study

NCT01166243 | Completed Phase 3 DMC

• 2 other identifiers: 400-10-0012010-019427-58
• Study Type: interventional
• Target: 84
• Locations: 5 countries
• Sites: 9

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.

Conditions

Hemorrhage

Keywords

Hemostasis

Outcome Measures

Primary Outcomes (1)

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

  Intra-operative

Secondary Outcomes (6)

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

  Intra-operative

• Absolute time to hemostasis

  Intraoperative

• Subjects requiring re-treatment

  Intraoperative

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

  Intraoperative through 60 days

• Incidence of adverse events potentially related to thrombotic events

  Intraoperative through 60 days

Study Arms (2)

Fibrin Pad

EXPERIMENTAL

Biologic

Biological: Fibrin Pad

Standard of Care

OTHER

Procedure

Procedure: Standard of Care

Interventions

Fibrin Pad BIOLOGICAL

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).

Fibrin Pad

Standard of Care PROCEDURE

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead
• OMRIX Biopharmaceuticals: collaborator

Study Sites (9)

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

The Alfred

Melbourne, Victoria, 3044, Australia

Location

University Hospital of the University of Saarland

Straße, D-66421, Germany

Location

University Medical Center

Groningen, 9713, Netherlands

Location

Auckland City Hospital

Grafton, 1010, New Zealand

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23216780 RESULT

• 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.

  PMID: 26636489 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeff Hammond, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

AU (3); DE (1); NZ (1); GB (3); NL (1)