The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Fibrin Pad 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).
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
Flinders Medical Centre
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
The Alfred
Melbourne, Victoria, Australia
University Hospital of the University of Saarland
Straße, Germany
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
Time frame: Intra-operative
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Time frame: Intra-operative
Absolute time to hemostasis
Time frame: Intraoperative
Subjects requiring re-treatment
Time frame: Intraoperative
Incidence of adverse events potentially related to re-bleeding at TBS
Time frame: Intraoperative through 60 days
Incidence of adverse events potentially related to thrombotic events
Time frame: Intraoperative through 60 days
Incidence of adverse events
Time frame: Intraoperative through 60 days
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University Medical Center
Groningen, Netherlands
Auckland City Hospital
Grafton, New Zealand
Queen Elizabeth Hospital
Birmingham, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom