DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron

NCT ID: NCT07038330

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1:1 randomization, one month administration,. two months follow up
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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30mg

1 cp (30mg) per day of Sucrosomial Iron

Group Type EXPERIMENTAL

Sucrosomial Iron

Intervention Type DRUG

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

60mg

2 cp (60mg) per day of Sucrosomial Iron

Group Type EXPERIMENTAL

Sucrosomial Iron

Intervention Type DRUG

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

120mg

4 cp (120mg) per day of Sucrosomial Iron

Group Type EXPERIMENTAL

Sucrosomial Iron

Intervention Type DRUG

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

Interventions

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Sucrosomial Iron

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Hb\>11.1, hematological primary disesases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Paolo P Weltert, MD

Role: PRINCIPAL_INVESTIGATOR

European Hospital

Central Contacts

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Luca P Weltert, MD

Role: CONTACT

+393478880617

References

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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.

Reference Type BACKGROUND
PMID: 34710946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35514874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36580029 (View on PubMed)

Other Identifiers

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SideralDose

Identifier Type: -

Identifier Source: org_study_id

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