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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01166243




Registration number
NCT01166243
Ethics application status
Date submitted
6/07/2010
Date registered
21/07/2010
Date last updated
20/01/2014

Titles & IDs
Public title
The Fibrin Pad Liver Study
Scientific 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
Secondary ID [1] 0 0
2010-019427-58
Secondary ID [2] 0 0
400-10-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhage 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fibrin Pad
Treatment: Surgery - Standard of Care

Experimental: Fibrin Pad - Biologic

Other: Standard of Care - Procedure


Other interventions: Fibrin 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).

Treatment: Surgery: Standard of Care
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
Timepoint [1] 0 0
Intra-operative
Secondary outcome [1] 0 0
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Timepoint [1] 0 0
Intra-operative
Secondary outcome [2] 0 0
Absolute time to hemostasis
Timepoint [2] 0 0
Intraoperative
Secondary outcome [3] 0 0
Subjects requiring re-treatment
Timepoint [3] 0 0
Intraoperative
Secondary outcome [4] 0 0
Incidence of adverse events potentially related to re-bleeding at TBS
Timepoint [4] 0 0
Intraoperative through 60 days
Secondary outcome [5] 0 0
Incidence of adverse events potentially related to thrombotic events
Timepoint [5] 0 0
Intraoperative through 60 days
Secondary outcome [6] 0 0
Incidence of adverse events
Timepoint [6] 0 0
Intraoperative through 60 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3044 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Strasse
Country [2] 0 0
Netherlands
State/province [2] 0 0
Groningen
Country [3] 0 0
New Zealand
State/province [3] 0 0
Grafton
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Birmingham
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Cambridge
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ethicon, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
OMRIX Biopharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01166243
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Hammond, MD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01166243