DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron
SideralDose
POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)
1 other identifier
interventional
150
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2025
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2025
CompletedStudy Start
First participant enrolled
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 26, 2025
June 1, 2025
4 months
June 5, 2025
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin
Hemoglobin level at 30 day of treatment
30 days
Secondary Outcomes (1)
Martial Metabolism
30 days
Study Arms (3)
30mg
EXPERIMENTAL1 cp (30mg) per day of Sucrosomial Iron
60mg
EXPERIMENTAL2 cp (60mg) per day of Sucrosomial Iron
120mg
EXPERIMENTAL4 cp (120mg) per day of Sucrosomial Iron
Interventions
Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp
Eligibility Criteria
You may not qualify if:
- Hb\>11.1, hematological primary disesases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 34710946BACKGROUNDVenturini 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: 35514874BACKGROUNDWeltert 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: 36580029BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Paolo P Weltert, MD
European Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 26, 2025
Study Start
June 23, 2025
Primary Completion
October 31, 2025
Study Completion
December 31, 2025
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
- Time Frame
- One year after closure of study
- Access Criteria
- Reasonable Request