DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron (SideralDose)

Cardiochirurgia E.H.

Status and phase: Not yet enrolling; Phase 4

Conditions: Anemia

Treatments: Drug: Sucrosomial Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT07038330

SideralDose

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

• Hb>11.1, hematological primary disesases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

30mg

Experimental group

Description:

1 cp (30mg) per day of Sucrosomial Iron

Treatment:

Drug: Sucrosomial Iron

60mg

Experimental group

Description:

2 cp (60mg) per day of Sucrosomial Iron

Treatment:

Drug: Sucrosomial Iron

120mg

Experimental group

Description:

4 cp (120mg) per day of Sucrosomial Iron

Treatment:

Drug: Sucrosomial Iron