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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,023
CardioSideral 2 caps per day
Cardiochirurgia European Hospital
Rome, Italy
Preoperative Hemoglobin Level
Preoperative Hemoglobin Level
Time frame: 30 days from enrollment
Compliance to drug
Discontinuation rate due to adverse effects
Time frame: 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
Time frame: 30 days after operation
Hemoglobin Level 24 hours after operation
Hemoglobin Level 24 hours after operation
Time frame: 24 hours after index operation
Hemoglobin Level 48 hours after operation
Hemoglobin Level 48 hours after operation
Time frame: 48 hours after index operation
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