DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron
- Registration Number
- NCT07038330
- Lead Sponsor
- Cardiochirurgia E.H.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Hb<11; Having had Heart Surgery, Being Discharged to Rehab
- Hb>11.1, hematological primary disesases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30mg Sucrosomial Iron 1 cp (30mg) per day of Sucrosomial Iron 60mg Sucrosomial Iron 2 cp (60mg) per day of Sucrosomial Iron 120mg Sucrosomial Iron 4 cp (120mg) per day of Sucrosomial Iron
- Primary Outcome Measures
Name Time Method Hemoglobin 30 days Hemoglobin level at 30 day of treatment
- Secondary Outcome Measures
Name Time Method Martial Metabolism 30 days Ferritin, Transferrin, Iron Saturation