Clinical trial NCT01993888: The EVARREST® Fibrin Sealant Patch Liver Study
Official title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhage
Keywords: Hepatobiliary Surgery
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 102
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: To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) 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 or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

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 EVARREST® 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 medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
* Female subjects who are pregnant or nursing.

Primary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
timeFrame: Intraoperative, 4 minutes following randomization
Secondary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization
timeFrame: Intraoperative, 10 minutes following randomization
measure: Absolute Time to Hemostasis
timeFrame: Intraoperative, an average of 4.2 minutes following randomization
measure: Incidence of Re-bleeding Events From the TBS During the Study Follow-up
timeFrame: Up to 60-days following surgery
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 60-days following surgery
measure: Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
timeFrame: Up to 60-days following surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Investigation Site #13
state: Alabama
city: Augusta
country: United States
facility: Clinical Investigation Site #10
state: Georgia
city: Chicago
country: United States
facility: Clinical Investigation Site #16
state: Illinois
city: Chicago
country: United States
facility: Clinical Investigation Site #12
state: Illinois
city: New Orleans
country: United States
facility: Clinical Investigation Site #15
state: Louisiana
city: St. Louis
country: United States
facility: Clinical Investigation Site #9
state: Missouri
city: New York
country: United States
facility: Clinical Investigation Site #11
state: New York
city: New York
country: United States
facility: Clinical Investigation Site #14
state: New York
city: Philadelphia
country: United States
facility: Clinical Investigation Site #8
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Investigation Site #17
state: Pennsylvania
city: Melbourne
country: Australia
facility: Clinical Investigation Site #3
city: Woodville South
country: Australia
facility: Clinical Investigation Site #2
city: Auckland
country: New Zealand
facility: Clinical Investigation Site #1
city: Birmingham
country: United Kingdom
facility: Clinical Investigation Site #6
city: Cambridge
country: United Kingdom
facility: Clinical Investigation Site #7
city: Edinburgh
country: United Kingdom
facility: Clinical Investigation Site #4
city: Leeds
country: United Kingdom
facility: Clinical Investigation Site #5
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD
role: STUDY_DIRECTOR
References:
citation: Koea JB, Batiller J, Aguirre N, Shen J, Kocharian R, Bochicchio G, Garden OJ. A multicentre, prospective, randomized, controlled trial comparing EVARREST fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection. HPB (Oxford). 2016 Mar;18(3):221-8. doi: 10.1016/j.hpb.2015.12.006. Epub 2016 Feb 1.
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.