DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron

NCT07038330 — Phase 4, Not yet recruiting, 150 participants, Cardiochirurgia E.H.

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POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)

Registry	NCT07038330, acronym SideralDose
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	Cardiochirurgia E.H. (Other)
Conditions	Anemia
Interventions	Sucrosomial Iron (Drug)
Dates	start 2025-06-23 (estimated), primary completion 2025-10-31 (estimated), completion 2025-12-31 (estimated), first posted 2025-06-26, last updated 2025-06-26

-Summary

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

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
30mg	Experimental	Drug: Sucrosomial Iron	1 cp (30mg) per day of Sucrosomial Iron
60mg	Experimental	Drug: Sucrosomial Iron	2 cp (60mg) per day of Sucrosomial Iron
120mg	Experimental	Drug: Sucrosomial Iron	4 cp (120mg) per day of Sucrosomial Iron

Sucrosomial Iron (Drug): Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp

+Outcome measures

Primary outcomes

Hemoglobin [30 days]: Hemoglobin level at 30 day of treatment

Secondary outcomes

Martial Metabolism [30 days]: Ferritin, Transferrin, Iron Saturation

+Eligibility

Sex: All

Inclusion Criteria: Hb<11; Having had Heart Surgery, Being Discharged to Rehab

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Exclusion Criteria:

* Hb>11.1, hematological primary disesases

+Publications

Results publication: 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. PMID 34710946
Results publication: 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. PMID 35514874
Results publication: 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. PMID 36580029

+Investigators

Luca Paolo P Weltert, MD, Principal investigator, European Hospital