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| ID | Type | Description | Link |
|---|---|---|---|
| MoH |
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This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | patients who will be treated in accordance with standard of care |
|
| II | Active Comparator | patients for which the Fibrin Fleece will be applied directly on the active bleeding site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fleece | Biological | Fibrin Patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of successes at 10 minutes following randomization | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of successes at 5 minutes following randomization | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Dekel, MD | Rabin MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnei-Zion MC | Haifa | Israel | ||||
| Meir MC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23137020 | Derived | Nativ O, Patel B, Shen J, Batiller J, Horn S, Hart JC. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study. BMC Nephrol. 2012 Nov 8;13:147. doi: 10.1186/1471-2369-13-147. |
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| ID | Term |
|---|---|
| D003094 | Collagen |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
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| Kfar Saba |
| Israel |
| Rabin MC | Tel Aviv | Israel |
| Sheaba MC | Tel Aviv | Israel |
| D012596 |
| Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |