DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron

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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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Hb>11.1, hematological primary disesases

Treatment and study plan

Sucrosomial Iron

Drug

Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp

Primary outcomes

Hemoglobin

Time frame: 30 days

Hemoglobin level at 30 day of treatment

Secondary outcomes

Martial Metabolism

Time frame: 30 days

Ferritin, Transferrin, Iron Saturation

Study contacts

Contact information is provided by the study sponsor or research team.

Luca P Weltert, MD

CONTACT

[email protected]

+393478880617

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

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

Acronym: SideralDose

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 26, 2025
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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