NCT07038330

DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cardiochirurgia E.H. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Sucrosomial Iron	Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp

Timeline

• Start date: 2025-06-23
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-06-26
• Last updated: 2025-06-26