The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical. Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery. At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (\<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to \[\>=\] 28 days from birth) to \<1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
University of Alabama Hospital
Birmingham, Alabama, United States
icahn School of Medicine at Mt Sinai
New York, New York, United States
Birmingham Chrildren's Hospital
Birmingham, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Absolute time to hemostasis
The absolute time to hemostasis, defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed.
Time frame: Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed
Hemostatic success at 4 minutes
Proportion of subjects achieving hemostatic success at 4 minutes following Target Bleeding Site (TBS) identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure.
Time frame: Intraoperative, 4 minutes after TBS identification
Hemostatic success at 10 minutes
Proportion of subjects achieving hemostatic success at 10 minutes following TBS identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure.
Time frame: Intraoperative, 10 minutes after TBS identification
No re-bleeding at the TBS
Proportion of subjects with no re-bleeding at the TBS.
Time frame: Intraoperative, from TBS identification to final fascial closure
Incidence of adverse events that are potentially related to bleeding at the TBS
Incidence of adverse events that are potentially related to bleeding at the TBS.
Time frame: Intraoperative to 30 (+/- 14) days
Incidence of adverse events that are potentially related to thrombotic events
Incidence of adverse events that are potentially related to thrombotic events.
Time frame: Intraoperative to 30 (+/- 14) days
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Southampton University Hospital
Southampton, United Kingdom
Incidence of re-treatment at the TBS
Time frame: Intraoperative, from TBS identification to final fascial closure
Incidence of Adverse Events
Time frame: Intraoperative to 30 (+/- 14) days
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (hemoglobin, hematocrit, and platelets) will be reported.
Time frame: Intraoperative to 30 days
Number of Participants with Estimated Intraoperative Blood Loss
Number of participants with estimated intraoperative blood loss will be reported.
Time frame: Intraoperative to 30 days
Number of Participants with Blood products Transfused
Number of participants with blood products transfused will be reported.
Time frame: Intraoperative to 30 days