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Lack of product due to industrial changes in the manufacturing process altering the final product.
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The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.
The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Traditional best-practice surgical hemostasis |
|
| Omni-stat Celox | Experimental | Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omni-stat Celox | Drug | Topical administration of 6 gr of Omnistat Celox |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of blood units transfused to the patients after surgery till discharge | 30 days | |
| Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery. | 3, 6, 12, 24 hours | |
| Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital | Rome | 00152 | Italy |
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| Control |
| Drug |
Traditional surgical Hemostasis |
|
| 1,2,3,5,7,10 minutes after application |