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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Clinical Investigation Site #13
Birmingham, Alabama, United States
Clinical Investigation Site #10
Augusta, Georgia, United States
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.
Time frame: Intraoperative, 4 minutes following randomization
Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization
Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.
Time frame: Intraoperative, 10 minutes following randomization
Absolute Time to Hemostasis
The absolute time to achieve hemostasis at or after 4 minutes from randomization.
Time frame: Intraoperative, an average of 4.2 minutes following randomization
Incidence of Re-bleeding Events From the TBS During the Study Follow-up
Time frame: Up to 60-days following surgery
Incidence of Adverse Events (AEs)
Time frame: Up to 60-days following surgery
Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
Number of participants with adverse events that were potentially related to thrombic events
Time frame: Up to 60-days following surgery
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Clinical Investigation Site #16
Chicago, Illinois, United States
Clinical Investigation Site #12
Chicago, Illinois, United States
Clinical Investigation Site #15
New Orleans, Louisiana, United States
Clinical Investigation Site #9
St Louis, Missouri, United States
Clinical Investigation Site #11
New York, New York, United States
Clinical Investigation Site #14
New York, New York, United States
Clinical Investigation Site #8
Philadelphia, Pennsylvania, United States
Clinical Investigation Site #17
Pittsburgh, Pennsylvania, United States
...and 7 more locations