Hemorrhage Clinical Trial
Official title:
A Non-Investigational Post-Market Trial Using EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.
This is a randomized, controlled single-center study observing the clinical utility of
EVARREST™ against standard of care (SoC) in controlling soft tissue bleeding. Standard of
care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or
any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her
standard of care. All subjects will be followed post-operatively through discharge and at 30
(+/-14) days.
Approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and
non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue
bleeding will be enrolled in the study. Subjects will be randomized on a 1:1 basis, EVARREST™
vs. SoC.
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