Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019427-58 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| OMRIX Biopharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Pad | Experimental | Biologic |
|
| Standard of Care | Other | Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Pad | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving hemostasis success at 10-minutes following randomization. | Intra-operative | |
| Absolute time to hemostasis | Intraoperative | |
| Subjects requiring re-treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeff Hammond, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia | ||
| Queen Elizabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23216780 | Result | Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16. | |
| 26636489 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Procedure | Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding. |
|
| Intraoperative |
| Incidence of adverse events potentially related to re-bleeding at TBS | Intraoperative through 60 days |
| Incidence of adverse events potentially related to thrombotic events | Intraoperative through 60 days |
| Incidence of adverse events | Intraoperative through 60 days |
| Woodville |
| South Australia |
| 5011 |
| Australia |
| The Alfred | Melbourne | Victoria | 3044 | Australia |
| University Hospital of the University of Saarland | Straße | D-66421 | Germany |
| University Medical Center | Groningen | 9713 | Netherlands |
| Auckland City Hospital | Grafton | 1010 | New Zealand |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21. |