CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery

Study Overview
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Brief Summary
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This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.

Detailed Description
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This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery. Secondary Objectives are Changes in blood chemistry and biochemical tests between pre- and post-intervention Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron Reduction in the number of transfusions and blood bags used Evaluation of cost-effectiveness

Official Title
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CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation

Conditions
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Anemia

Intervention / Treatment
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* Drug: Sucrosomial Iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing elective Heart Surgery - Exclusion Criteria: - Emergent or Urgent Indication
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization of 1000 consecutive patients undergoing heart surgery to either Iron supplementation or Control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CardioSIDERAL<br>Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation | Drug: Sucrosomial Iron<br>* CardioSideral 2 caps per day<br>* Other names: CardioSideral;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Hemoglobin Level | Preoperative Hemoglobin Level | 30 days from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to drug | Discontinuation rate due to adverse effects | 30 days from enerollemnt | 
| Cost-effectiveness in terms of cost of drug vs saved blood units | Cost-effectiveness in terms of cost of drug vs saved blood units | 30 days after operation | 
| Hemoglobin Level 24 hours after operation | Hemoglobin Level 24 hours after operation | 24 hours after index operation | 
| Hemoglobin Level 48 hours after operation | Hemoglobin Level 48 hours after operation | 48 hours after index operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Heart Surgery, Iron Supplementation