DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sucrosomial Iron.
- Who it may be relevant to
- Registry conditions: Anemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)
Overview
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.
Interventions
- Drug Sucrosomial Iron
Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp
Primary outcome measures
- Hemoglobin [Time frame: 30 days]
Secondary outcome measures (1)
- Martial Metabolism [Time frame: 30 days]
Eligibility criteria
Inclusion Criteria: Hb<11; Having had Heart Surgery, Being Discharged to Rehab
\-
Exclusion criteria
- Hb>11.1, hematological primary disesases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07038330 · SideralDose