Clinical trial NCT01166243: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhage
Keywords: Hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2010-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
timeFrame: Intra-operative
Secondary outcomes:
measure: Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
timeFrame: Intra-operative
measure: Absolute time to hemostasis
timeFrame: Intraoperative
measure: Subjects requiring re-treatment
timeFrame: Intraoperative
measure: Incidence of adverse events potentially related to re-bleeding at TBS
timeFrame: Intraoperative through 60 days
measure: Incidence of adverse events potentially related to thrombotic events
timeFrame: Intraoperative through 60 days
measure: Incidence of adverse events
timeFrame: Intraoperative through 60 days
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Strasse
country: Germany
facility: University Hospital of the University of Saarland
city: Groningen
country: Netherlands
facility: University Medical Center
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: Ethicon, Inc.
name: Jeff Hammond, MD
role: STUDY_DIRECTOR
References:
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.
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.