Brief Summary

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Aug 2009

Geographic Reach

4 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

August 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

September 15, 2009

Last Update Submit

September 30, 2015

Conditions

Soft Tissue Bleeding

Keywords

Hemostasis

Outcome Measures

Primary Outcomes (1)

Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
Intra-operative

Secondary Outcomes (7)

Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Intra-operative
Absolute time to hemostasis
Intra-operative
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Intra-operative
Incidence of treatment failures
Intra-operative
Incidence of adverse events that are potentially related to bleeding at the TBS
Intra-operative through 60 days
+2 more secondary outcomes

Study Arms (2)

Fibrin Pad

EXPERIMENTAL

Biological: Fibrin Pad

Standard of Care

ACTIVE COMPARATOR

Procedure: Standard of Care

Interventions

Fibrin PadBIOLOGICAL

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 CarePROCEDURE

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

Standard of Care

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects \>= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
Presence of an appropriate severe bleeding soft tissue 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;
Bleeding site 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;
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;
Subjects unwilling to receive blood products;
Subjects with known immunodeficiency diseases (including known HIV);
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 enrollment;
Female subjects who are pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ethicon, Inc.lead

Study Sites (17)

Bankstown Hospital

Bankstown, Australia

Location

Flinders Medical Centre

Bedford Park, Australia

Location

The Townsville Hospital

Douglas, Australia

Location

Royal Melbourne Hospital

Parkville, Australia

Location

University Hospital of the University of Saarland

Homburg/Saar, Homburg/Saar, D-66421, Germany

Location

Department of Surgery, University of Heidelberg

Heidelberg, 69120, Germany

Location

Krankenhaus Salem

Heidelberg, 69121, Germany

Location

Vincentius-Klinken

Karlsruhe, Germany

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Auckland City Hospital

Auckland, New Zealand

Location

North Shore Hospital

Auckland, New Zealand

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

The Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

St. James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 2BE, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (3)

Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Erratum to: Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Oct;39(10):2610. doi: 10.1007/s00268-015-3163-9. No abstract available.
PMID: 26216641RESULT
Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Nov;39(11):2663-9. doi: 10.1007/s00268-015-3106-5.
PMID: 26041587RESULT
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: 26636489DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

James Hart, MD
Ethicon, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

DE(4)NZ(3)AU(4)GB(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Fibrin Pad

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (3)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations