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Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments.
Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrosomial® Iron | Experimental | Patients will receive iron supplementation with Sucrosomial® Iron |
|
| Iron Sucrose injections. | Active Comparator | Patients will receive standard of care Iron Sucrose injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrosomial Iron (SI) | Dietary Supplement | The Sucrosomial Iron (SI) you may receive is a considered a supplement, so it has not been approved by the U.S. Food & Drug Administration (FDA) for sale. However, it is available for over-the-counter purchase. Sucrosomial Iron (SI) has been developed by PharmaNutra. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin levels | Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care. | 30 days |
| Financial Cost | Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV) | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion requirements | Reduction in transfusion requirements, measured by the number of transfusions needed during the study period. | 30 Days |
| Length of Stay | Length of hospital stay measured from the date of surgery to discharge. Length of ICU stay measured from date of surgery to date of ICU discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Englewood Hospital | Recruiting | Englewood | New Jersey | 07631 | United States |
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|
| 30 Days |
| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
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