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Randomization to different doses of Sucrosomial Iron for one moth after discharge to rehab after heart surgery to assess if more iron grants a faster recovery or not
Evaluation of the efficacy of short-term sucrosomial iron treatment in patients undergoing cardiac surgery and subsequently transferred to rehabilitation, measured in terms of increase in hemoglobin values and restoration of martial blood parameters, administering doses of 30mg, 60mg and 120mg respectively, after randomization of patients.
Numerical congruity analysis, power sampling, biometric characteristics of internal compatibility between cohorts and outcome analysis with comparison for continuous homoscedastic case-control variables
Drafting of formal statistical analysis, drafting of information synopsis, writing, validation, forwarding to scientific journal and correction until obtaining, where possible, publications of the manuscript relating to the research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30mg | Experimental | 1 cp (30mg) per day of Sucrosomial Iron |
|
| 60mg | Experimental | 2 cp (60mg) per day of Sucrosomial Iron |
|
| 120mg | Experimental | 4 cp (120mg) per day of Sucrosomial Iron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrosomial Iron | Drug | Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Hemoglobin level at 30 day of treatment | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Martial Metabolism | Ferritin, Transferrin, Iron Saturation | 30 days |
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Inclusion Criteria: Hb<11; Having had Heart Surgery, Being Discharged to Rehab
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca P Weltert, MD | Contact | +393478880617 | lweltert@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luca Paolo P Weltert, MD | European Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34710946 | Result | Pierelli L, De Rosa A, Falco M, Papi E, Rondinelli MB, Turani F, Weltert L. Preoperative Sucrosomial Iron Supplementation Increases Haemoglobin and Reduces Transfusion Requirements in Elective Heart Surgery Patients: A Prospective Randomized Study. Surg Technol Int. 2021 Oct 28;39:321-328. doi: 10.52198/21.STI.39.CV1512. | |
| 35514874 |
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One year after closure of study
Reasonable Request
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
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1:1:1 randomization, one month administration,. two months follow up
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| Venturini E, Iannuzzo G, DI Lorenzo A, Cuomo G, D'Angelo A, Merone P, Cudemo G, Pacileo M, D'Andrea A, Vigorito C, Giallauria F. Short-term treatment of iron deficiency anemia after cardiac surgery. Int J Cardiol Heart Vasc. 2022 May 2;40:101038. doi: 10.1016/j.ijcha.2022.101038. eCollection 2022 Jun. |
| 36580029 | Result | Weltert LP, De Rosa A, Rondinelli MB, Falco M, Turani F, Pierelli L. Benefits of pre-operative oral Sucrosomial(R) iron supplementation in cardiac surgery: influence of patient's baseline hemoglobin and gender. Blood Transfus. 2023 Jul;21(4):305-313. doi: 10.2450/2022.0222-22. Epub 2022 Nov 25. |