Anemia
Conditions
Keywords
Sucrosomial Iron, Oral Iron, Post Cardiac Surgery Rehabilitation
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
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
DRUGSucrosomial Iron
Sideral Forte, Italian market formulation of Sucrosomila Iron 30mg per cp
Sponsors
Cardiochirurgia E.H.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1:1 randomization, one month administration,. two months follow up
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Hb\<11; Having had Heart Surgery, Being Discharged to Rehab \-
Exclusion criteria
* Hb\>11.1, hematological primary disesases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 30 days | Hemoglobin level at 30 day of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Martial Metabolism | 30 days | Ferritin, Transferrin, Iron Saturation |
Contacts
Primary ContactLuca P Weltert, MD
Outcome results
None listed