Overview

This trial is active, not recruiting.

Condition hemorrhage
Treatments evarrest™ fibrin sealant patch, standard of care (soc)
Phase phase 3
Sponsor Ethicon, Inc.
Start date October 2013
End date July 2014
Trial size 90 participants
Trial identifier NCT01993888, 2013-002535-24, BIOS-13-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
EVARREST™ Fibrin Sealant Patch 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).
evarrest™ fibrin sealant patch
(Other)
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
standard of care (soc)

Primary Outcomes

Measure
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes following randomization
time frame: Intraoperative

Secondary Outcomes

Measure
Hemostasis at the Target Bleeding Site (TBS) at 10-minutes following randomization
time frame: Intraoperative
Incidence of adverse events
time frame: up to 60-days
Absolute time to hemostasis
time frame: Intraoperative

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Ethicon, Inc..